BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1951969 · Received January 3, 2011

    Report

    Report Number
    MW5018872
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ABBOTT
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A VETERAN WHO RECEIVES HEALTH CARE FROM THE (B)(6). I HAVE TYPE I INSULIN DEPENDENT DIABETES. I WAS ISSUED A PRECISION XTRA BLOOD GLUCOSE TESTING METER. I HAVE SEEN THE ABBOTT LABS AND FDA RECALL OF BLOOD TEST STRIPS. MY LOT 45001A753, IS LISTED IN THE RECALL NOTICE. WHEN I USED IT YESTERDAY, IT APPARENTLY GAVE ME A FALSE LOW READING. AS A RESULT, I FAILED TO TAKE ENOUGH INSULIN. I WOKE UP EARLY THIS MORNING, HAS SEVERE SYMPTOMS OF HYPERGLYCEMIA, VOMITING. THE TEST RESULT THEN SHOWED HI, MEANING OVER 500 MG/DL. I TOOK 25 UNITS OF HUMULIN R INSULIN. FIVE HRS LATER, THE READING WAS 333 MG/DL, I TOOK 18 MORE UNITS OF REGULAR INSULIN. EXTRAPOLATING BACKWARDS, I SUSPECT THE FIRST MORNING READING WAS IN THE 700-800 MG/DL RANGE. I STOPPED USING THE DEFECTIVE LOT AND RECOMMEND NO ONE CONTINUE TO USE THIS LOT. DOSE OR AMOUNT: ONE; FREQUENCY: 4-5 TIMES DAILY; ROUTE: CUTANEOUS. DATES OF USE: 4 YRS. DIAGNOSIS OR REASON FOR USE: TYPE I INSULIN DEPENDENT DIABETES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD TEST STRIPS, 100 NBW ABBOTT 45001A753

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| O