BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METER

    MDR report key: 1030747 · Received April 17, 2008

    Report

    Report Number
    2939301-2008-00588
    Event Type
    Injury
    Date Received
    April 17, 2008
    Report Date
    April 14, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT AN UNSPECIFIED ONE TOUCH METER AND TEST STRIPS WERE GIVING INACCURATELY HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER SERVICE REP (CSR) WAS UNABLE TO CORRESPOND WITH THE PT TO OBTAIN/VERIFY INFO. A LETTER WAS MAILED TO PT ON FOUR DAYS LATER, IN AN ATTEMPT TO CONTACT THE PT FOR FOLLOW-UP QUESTIONING. IT IS NOT KNOWN EXACTLY WHICH "ONE TOUCH" DEVICE AND TEST STRIPS THE PT WAS USING. THE PT DISCONNECTED THE CALL WITH THE CSR BEFORE PROVIDING ANY PRODUCT NAMES, LOT NUMBERS, AND SERIAL NUMBERS ASSOCIATED WITH THE ALLEGATION. THE PT, HOWEVER, CLAIMED THAT HE GOT INACCURATE HIGH METER RESULTS WHILE USING CODE 4 TEST STRIPS. AS A RESULT, THE PT ALLEGED THAT HE TOOK INSULIN ACCORDINGLY AND SUFFERED FROM HYPOGLYCEMIA. WHEN THE PT USED CODE 7 TEST STRIPS, HE REPORTEDLY DID NOT HAVE ANY PROBLEMS. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: WHAT METER AND TEST STRIPS THE PT WAS USING, WHEN THE ALLEGED ISSUE BEGAN, WHAT SPECIFIC SYMPTOMS HE HAD, WHEN THE SYMPTOMS STARTED, AND THE DETAILS OF HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT METER RESULT(S) THE PT ALLEGED WERE INACCURATELY HIGH, WHAT DATES/TIMES THE RESULTS WERE OBTAINED, WHAT TYPE AND DOSAGE OF INSULIN THE PT TOOK, WHAT DATE/TIME THE INSULIN WAS TAKEN, AND WHAT ACTIONS THE PT TOOK IN RESPONSE TO DEVELOPING SYMPTOMS. THIS COMPLAINT IS BEING REPORTED DUE TO FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE TOOK INSULIN BASED ON AN ALLEGED INACCURATE HIGH METER RESULT AND SUFFERED HYPOGLYCEMIA AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN METER GLUCOSE MONITORING KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening