BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH SURESTEP METER

    MDR report key: 1231904 · Received November 12, 2008

    Report

    Report Number
    2939301-2008-03066
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008,THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH SURESTEP METER HAD A CALCODING ISSUE. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE TO THE PATIENT ON NOVEMBER 10, 2008, AND OBTAINED/VERIFIED INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE TWICE A DAY. SHE TESTS BEFORE BREAKFAST AND DINNER. THE PATIENT TAKES SET DOSES OF METFORMIN 3 TIMES A DAY. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON THE DAY LFS WAS CONTACTED, AT 12:25 PM. THE PATIENT EXPLAINED THAT ONE OF THE BUTTONS ON HER METER WAS NOT WORKING, AND THEREFORE, SHE WAS UNABLE TO CHANGE THE METER'S CODE. SINCE THE PATIENT WAS UNABLE TO CHANGE THE METER'S CODE, SHE DECIDED NOT TO TEST HER BLOOD GLUCOSE AND PROCEEDED TO TAKE HER USUAL DOSE OF METFORMIN. AT AROUND 1:05 PM THE SAME DAY, THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF SWEATING AND FEELING WEAK. THE PATIENT TREATED HERSELF BY DRINKING ORANGE JUICE WHICH HELPED TO RELIEVE HER SYMPTOMS. THE PATIENT DENIED SEEKING OR RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. THE PATIENT WAS NOT SURE IF SHE COULD HAVE DONE ANYTHING TO PREVENT THE SYMPTOMS. THE ALLEGED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH SURESTEP METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R