BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH

    MDR report key: 111638 · Received August 6, 1997

    Report

    Report Number
    2939301-1997-00055
    Event Type
    Injury
    Date Received
    August 6, 1997
    Date of Event
    July 3, 1997
    Report Date
    August 6, 1997
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CO HAS COMPLETED CO'S INVESTIGATION OF THE MDR INCIDENT DOCUMENTED IN CO'S INITIAL REPORT AND AFTER TESTING THE DEVICE, HAS NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION. THE METER READ OUTSIDE OF ITS LABELED CALIBRATION RANGE UPON RECEIPT AT LIFESCAN. THE METER HAD NOT BEEN PROPERLY CLEANED; THERE WAS DRIED BLOOD AND DIRT PRESENT ON THE OPTICS WINDOW. AFTER THE OPTICS WINDOW WAS CLEANED, THE METER READ WITHIN CALIBRATION RANGE AND REPORTED BLOOD GLUCOSE RESULTS IN ACCORDANCE WITH OUR PERFORMANCE SPECIFICATIONS. CO CONCLUDES THAT THE ALLEGED INACCURATE TEST RESULTS WERE DUE TO THE USER'S FAILURE TO PROPERLY CLEAN AND MAINTAIN THE METER AND FAILURE TO PERFORM DAILY CALIBRATION CHECKS WHICH ARE INTENDED TO DETECT THIS TYPE OF CONDITION; AS INSTRUCTED IN THE PRODUCT LABELING. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED.

    Description of Event or Problem · 1

    THE PT, A IDDM, BEGAN FEELING ILL ON 7/1 WITH SYMPTOMS OF "FOOD POISONING". HER SYMPTOMS CONTINUED UNTIL 7/3 WHEN NEIGHBORS TRANSPORTED HER TO THE EMERGENCY ROOM OF A LOCAL HOSP (SHE IS LEGALLY BLIND). SHE WAS ADMITTED AND TREATED FOR HIGH BLOOD SUGAR AND DEHYDRATION WITH IV INSULIN AND FLUIDS. IT WAS REPORTED THAT HER ONE TOUCH METER RESULTS PRIOR TO TRANSPORT TO THE HOSP WERE "EXTREMELY LOW: (NO EXACT RESULTS KNOWN). HER ADMISSION BLOOD GLUCOSE LEVEL WAS "OVER 500." THE PT "THINKS" SHE HAD NOT BEEN TAKING HER REGULAR INSULIN FOR 2-3 DAYS BECAUSE THE BOTTLE MAY HAVE BEEN EMPTY. METER MAINTENANCE (CLEANING AND QUALITY CONTROL TESTS) IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BLOOD GLUCOSE METER CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R