BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1984171 · Received February 10, 2011

    Report

    Report Number
    1823260-2011-00775
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFERENCE MEDWATCH REPORTS WITH PATIENT IDENTIFIERS (B)(6) FOR THE SECOND AND THIRD SUSPECT DEVICES (CUSTOMER DID NOT KNOW WHICH DEVICE PRODUCED WHICH RESULT).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 150 MG/DL ON COMPACT PLUS SYSTEM 1, 380 MG/DL ON COMPACT PLUS SYSTEM 2, AND 170 MG/DL ON COMPACT PLUS SYSTEM 3 WITHIN 10 MINUTES. 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 20726746

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR HUMALOG "N"| CARDIAC MONITOR| HUMALOG "R"