BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1982810 · Received February 9, 2011

    Report

    Report Number
    1823260-2011-00737
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE COMPACT PLUS METER 2. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE COMPACT PLUS METER 1.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 43 MG/DL (COMPACT PLUS METER 1) AND 77 MG/DL (COMPACT PLUS METER 2) 49 MG/DL, 92 MG/DL, AND 59 MG/DL (COMPACT PLUS METER 1) AND 47 MG/DL, 56 MG/DL, AND 70 MG/DL (COMPACT PLUS METER 2) SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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
    1 077 YR PREDNISONE| LEVAQUIN| PACEMAKER| INHALER| HUMALOG