BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1023401 · Received April 2, 2008

    Report

    Report Number
    1823260-2008-02929
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 25, 2006
    Report Date
    April 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE VALUE IN THE 300S MG/DL RANGE ON THE VOICEMATE ADVANTAGE SYSTEM BACK TO BACK WITH A RESULT IN THE 100S MG/DL RANGE ON A PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT AT A DIFFERENT TIME ANOTHER COMPARATIVE TEST IN THE 150-180 MG/DL RANGE WAS PERFORMED ON THE SAME VOICEMATE ADVANTAGE SYSTEM BACK TO BACK WITH A RESULT OF ABOUT 100 MG/DL WITHIN 10 MINUTES ON THE ANOTHER PROFESSIONAL SYSTEM. REPORTER ALSO STATED THAT HE TOOK 5 UNITS OF INSULIN WHEN HIS RESULT WAS OVER 200 MG/DL ON THE SAME VOICEMATE ADVANTAGE SYSTEM, THAT HE PASSED OUT 45 MINUTES LATER, AND A RESULT OF 34 WAS OBTAINED IN THE ER. HE STATED THAT HE WAS POSSIBLY TREATED BY THE EMTS WITH GLUCOSE GEL, BUT IT IS UNCERTAIN IT IF WAS DURING THIS EPISODE OR ANOTHER. NO ACTION ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R LISINOPRIL - 10MG TWICE DAILY| ASPIRIN - 325MG ONCE DAILY| LANTUS - SLIDING SCALE| LIPITOR - 10MG ONCE DAILY| PROGRAF - 1.5MG DAILY| METOPROLOL - 50MG ONCE DAILY