BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761342 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06348
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    June 29, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A BLOOD GLUCOSE VALUE OF 416 MG/DL ON HER COMPACT SYSTEM AND DOSED 5 UNITS OF RAPID INSULIN BASED ON THE RESULT. REPORTER STATED PASSING OUT 30 MINUTES LATER AND WHEN SHE AWAKENED, SELF TREATED WITH A SODA. REPORTER STATED READINGS ON THE SYSTEM PRIOR TO THE ALLEGED INCIDENT WERE 42 MG/DL BACK TO BACK WITH A RESULT OF 218 MG/DL WHEN TESTING WAS PERFORMED WITHIN TEN MINUTES. REPORTER INDICATED NOT EXPERIENCING ANY HYPERGLYCEMIC OR HYPOGLYCEMIC SYMPTOMS DURING THE ALLEGED INCIDENT OR WHILE PERFORMING THE COMPARATIVE TESTING. NO OTHER ACTIONS TAKEN OR TREATMENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    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 20647541

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR LISINOPRIL 4YRS - 10MG ONCE DAILY| MINI MED 508 PUMP 7YRS - CONTINUOUS| HUMALOG 33YRS - SLIDING SCALE