BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1941417 · Received December 29, 2010

    Report

    Report Number
    1823260-2010-07743
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 22, 2010
    Report Date
    February 2, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 297 MG/DL AND 131 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. HIGH BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER HAD TAKEN INSULIN AFTER TESTING 297 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 207274

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR XANAX| FLONASE| DUONEB "INOLATOR"| LORAZEPAM| ULTRAM| LANTUS| METFORMIN| LASIX| PLAVIX| CRESTOR| ADVAIR| NEXIUM| HUMALOG| ALTACE| METANX| "TOPOL"| SINGULAIR