BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2001352 · Received February 25, 2011

    Report

    Report Number
    1823260-2011-01032
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 14 MG/DL AND 73 MG/DL. CUSTOMER WAS FEELING SHAKY WITH AN INITIAL READING OF 15 MG/DL. CUSTOMER TOOK ANOTHER READING OF 14 MG/DL. CUSTOMER WAS ABLE TO SELF-TREAT WITH A CINNAMON ROLL AND A PIZZA/NOODLE DISH. CUSTOMER THEN OBTAINED A READING OF 73 MG/DL. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT 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 ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR METFORMIN| SIMVASTATIN| ACTOS| LISINOPRIL| FENOFIBRATE| CPAP MACHINE| BABY ASPIRIN 1X DAILY