BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1041209 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03899
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 321 MG/DL, 321 MG/DL AND 121 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS ON THE COMPACT PLUS SYSTEM. REPORTER INDICATED THAT SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. REPORTER STATED THAT THE FIRST LEVEL OF CONTROL WAS RUN ON THE SYSTEM AND WAS WITHIN RANGE. 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 20664242

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR TRAZODONE| ADDERALL XR| DIOVAN HCTZ 160/25 ONCE DAILY| EFFEXOR XR- 150MG TWICE DAILY| FOSAMAX| IMITREX| DIFLUCAN| TOPROL XL| ACETAMINOPHEN| LISINOPRIL| RELAFEN- 1 MONTH| ASPIRIN| PREVACID| KLOR-CON| ZOCOR| XANAX