BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC

    MDR report key: 93288 · Received May 22, 1997

    Report

    Report Number
    2939301-1997-00038
    Event Type
    Injury
    Date Received
    May 22, 1997
    Date of Event
    January 28, 1997
    Report Date
    May 22, 1997
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CO HAS COMPLETED THE INVESTIGATION OF THE MDR INCIDENT 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 DIRT AND SCRATCHES PRESENT ON THE OPTICS WINDOW. AFTER THE METER OPTICS WINDOW WAS CLEANED, THE METER READ WITHIN CALIBRATION RANGE AND REPORTED BLOOD GLUCOSE RESULTS IN ACCORDANCE WITH OUR PERFORMANCE SPECS. 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

    AT 8/A ON 1/28, THE PT TESTED HER BLOOD GLUCOSE ON HER ONE TOUCH BASIC METER WITH A RESULT OF 102 MG/DL. SHE CONSUMED BREAKFAST AND TOOK HER USUAL DOSE OF 38U 70/30 INSULIN. BECAUSE SHE DID NOT "LOOK WELL" AND WAS "NUMB" SHE WAS TRANSPORTED PRIVATELY TO THE HOSPITAL WHERE THE ER METER (ACCUCHECK) RESULT WAS "OVER 400." THE PT WAS TREATED IN THE ER WITH "SOMETHING TO BRING IT (BLOOD GLUCOSE) DOWN" AND ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF "POSSIBLE MINI STROKE." SHE WAS SUBSEQUENTLY RELEASED 3 DAYS LATER. THE MFR HAS RECEIVED THE METER AND PERFORMED PRELIMINARY TESTING WHICH INDICATES AN OUT OF CALIBRATION (LOW) CONDITION DUE TO THE PRESENCE OF DRIED BLOOD AND DIRT ON THE METER OPTICS. IT WAS REPORTED THAT THE METER WAS CLEANED WITH ALCOHOL RATHER THAN THE RECOMMENDED WATER AND THAT QUALITY CONTROL TESTS DESIGNED TO DETECT THIS TYPE OF CONDITION ARE NOT PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R