...for as long as it takes
By Public Affairs Branch, Tricare Management Activity
Tricare Management Activity, Aurora, CO
A manufacturer of blood glucose monitors has
announced that it is recalling and will replace some of its
home blood glucose meters because of possible
malfunctions.
The malfunctions could cause users to fail to recognize seriously high blood glucose levels. This failure could cause serious health consequences, including hospitalization - and even death.
Lifescan, Inc., a subsidiary of Johnson & Johnson, announced the recall of its SureStep home glucose meters that were manufactured before August 1997, because the meters may give an incorrect reading when a patient's blood glucose is very high.
The meters may wrongly give an 'ER1' (Error 1) message instead of 'HI' (high) message if the user's blood glucose level is dangerously high (500 mg/dL or greater). Such a level is dangerous if not recognized and treated, and could result in hospitalization or death.
All SureStep blood glucose meters whose serial numbers begin with L6000 through L7205, and meters with serial numbers L7206-GA-00001 through L7206-GA-01128, should be replaced. The serial numbers can be found on the back of the meter. Lifescan, Inc., will replace any SureStep meter manufactured before August 1997 free of charge, with a new meter.
TRICARE-eligible persons who have these monitors should call Lifescan's 24-hour, toll-free customer service line at 1-800-951-7226, to arrange for replacement, or to get further information.
Also, the meter was designed to emit an audible tone when the test strip is inserted. A user may misinterpret this tone as an indication that the test strip was completely and properly inserted in the meter. When the test strip is not completely and properly inserted, an "inadequate test strip insertion problem" (ISIP) occurs. This defect has resulted in the meter displaying a false low reading, which could cause the patient to alter his/her insulin intake and/or diet when such alterations may not be necessary.
Lifescan claims it minimized the ISIP with a test strip modification that was effective around March 1998. Newer test strips can be identified by the elongated blood sample area.
Diabetics who use these SureStep blood glucose monitors should not stop testing their blood sugar levels. Diabetics should continue to test with these meters until they can get a replacement, as long as they remember that an 'ER1' message can mean a very high level of blood sugar, and that the ISIP problem causes false low readings.
If users get an 'ER1' message, Lifescan suggested that patients use the visual color change indicator to see if their blood sugar is too high. Users should compare the blue color dot on the test strip to the color chart on the test strip bottle, to check that the meter is working properly. However, Lifescan emphasized: "DO NOT use the Visual Backup color chart as a replacement for a SureStep meter test." If the dot on the strip is as dark as, or darker than the darkest oval on the color chart, it indicates a very high blood sugar. Any user who gets such a result should contact a health care professional immediately.
Again - TRICARE-eligible persons who use the monitors and test strips described above should make sure to get replacements from the manufacturer.
The Department of Defense?s inspector general (DOD-IG) asks any individual users of the SureStep or SureStep Pro glucose monitoring meters who have personal knowledge of, or experience with, either the ER 1 message or the ISIP, to contact the Defense Criminal Investigative Service (DCIS) - the investigative arm of the DOD-IG.
SureStep meter users should e-mail their personal experiences to DCIS at the DoD Hotline
Those who want to provide information on their experiences with the ER 1 message and/or the ISIP should include: (1) the patient?s name; (2) the meter operator?s name; (3) their conventional and electronic mailing addresses; (4) telephone numbers where both the patient and operator can be contacted; (5) the SureStep meter model name and serial number; (6) specific information regarding the error messages; and (7) whether the patient was hospitalized after experiencing meter problems.
The DoD Hotline provides confidentiality for persons who want to remain anonymous. Persons whose identity does not need to be withheld from DCIS should indicate that they don't need confidentiality in their e-mail to the Hotline.
DCIS wants only information that reflects problems experienced with the ER 1 message or the ISIP - whether or not they resulted in hospitalization.
E-mails should be brief and concise. Persons who want to speak to an agent should call DCIS at (510) 637-2965 between 8 a.m. and 4:30 p.m., Pacific Standard Time.
In addition to the e-mail address, the DoD Hotline for fraud, waste and abuse reporting can be reached toll-free, at 1-800-424-9098. Or, write to: Defense Hotline, The Pentagon, Washington, DC, 20301-1900.
For more TRICARE information, visit the Military Health System
Disclaimer of Endorsement:
Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not necessarily constitute or imply its endorsement, recommendation, or favoring by VNIS. The views and opinions of authors expressed herein do not necessarily state or reflect those of VNIS, and shall not be used for advertising or product endorsement purposes. VNIS is not a government agency and is a sole proprietorship, own and operated by Christian L. Wilson USN/Ret
