BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1133187 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06389
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT SHE OBTAINED THE BG RESULT OF 100MG/DL ON THE ACCU-CHEK COMPACT PLUS SYSTEM. SHE FELT HYPERGLYCEMIC. HER NORMAL BG RANGE IS 100-155MG/DL. WITHIN 10 MINUTES, HER BG WAS 267 MG/DL ON HER PHYSICIAN'S METER. HER PHYSICIAN TREATED HER WITH 30 UNITS OF LANTUS. THE RESULTS OF THE TREATMENT UNDISCLOSED. DURING A SEPARATE EVENT (PER METER MEMORY), THE CUSTOMER REPORTEDLY REC'D THE FOLLOWING RESULTS ON THE ACCU-CHEK COMPACT PLUS SYSTEM: 100MG/DL, 140MG/DL AND 63 MG/DL. THE TEST RESULTS WERE OBTAINED WITHIN 10 MINUTE TIMEFRAMES WITH EACH SET OF COMPARISONS. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED WITH THE SECOND SET OF COMPARISONS. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20682041

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention HUMALOG - 2 YEARS| FLEXERIL| MULTIVITAMIN| ADVAIR| COMBIVENT| LANTUS - THIS MONTH| VICODIN| ALBUTEROL| DILANTIN