BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE

    MDR report key: 469016 · Received June 25, 2003

    Report

    Report Number
    MW1028835
    Event Type
    Malfunction
    Date Received
    June 25, 2003
    Date of Event
    June 24, 2003
    Report Date
    June 25, 2003
    Manufacturer
    ROCHE
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LOW BLOOD SUGAR RESULTED FROM QUALITY CONTROL ISSUE REGARDING ACCU-CHEK TEST STRIPS USED TO MEASURE BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE ACCU-CHECK TEST STRIPS CFR ROCHE * 546307
    2 ACCU-CHEK ADVANTAGE GLUCOSE METER CFR ROCHE READINGS IN MG/DL *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR HUMILOG. DINNER: 8 / 10UNITS / 12UNITS / 14UNITS| HUMILOG. LUNCH: 6 / 8UNITS / 10UNITS / 12UNITS| HUMILOG. 10MG PRINIVIL 20MG PROVACHOL.| PRIOR TO MEALS: GLUCOSE: <100 /100-150 /150-200 /| >200 BREAKFAST: 6 / 8UNITS / 10UNITS / 12UNITS| INSULIN: 24 UNITS OF LANTUS PRIOR TO BED SLIDING| SCALE FOR HUMILOG BASED ON GLUCOSE MEASUREMENT