BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD TEST STRIPS

    MDR report key: 1022290 · Received January 24, 2008

    Report

    Report Number
    MW5006091
    Event Type
    Other
    Date Received
    January 24, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 7, 2008
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATES SHE TOOK GLUCOSE READINGS PRIOR TO LUNCH WHICH READ 335. PT RETESTED, 328 WITH RETEST. PT THEN BOLUSED 6.6 UNITS HUMALOG VIA INSULIN PUMP. RETESTED 10 MINS LATER. STILL IN 300'S. BEGAN FEELING SX OF HYPOGLYCEMIA. TESTED ONCE MORE/STILL IN 300S. STATES HER SPS WHO IS NOT DIABETIC TESTED HIS BLOOD ALSO AND OBTAINED A 315 READING. PT THEN USED AN OLD METER AND OBTAINED BLOOD GLUCOSE LEVEL OF 40. STATES SHE CONSUMED ORANGE JUICE AND SUGAR TO TREAT HYPOGLYCEMIA. FELT BETTER AS DAY WENT ON. NO DR VISITS OR HOSPITALIZATION. THERAPY DATES: HAS BEEN USING BD STRIPS APPROX 5-6 YRS. DIAGNOSIS FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD TEST STRIPS BD NBW 7064129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other