BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1891668 · Received November 5, 2010

    Report

    Report Number
    1823260-2010-06600
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 5, 2010
    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.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 360 MG/DL ON THE COMPACT PLUS SYSTEM PRIOR TO PASSING OUT. REPORTER STATED THAT AN AMBULANCE WAS CALLED, ARRIVED 15-20 MINUTES LATER, AND TREATED HER IN AN UNSPECIFIED WAY AFTER OBTAINING THE RESULTS OF 59 MG/DL, 60 MG/DL AND 30 MG/DL ON THEIR SYSTEM. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED AS THERE WAS NOT A DELAY IN TREATMENT DUE TO THE 360 MG/DL RESULT. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT THE DRUM OF STRIPS USED WERE DISCARDED, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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
    1 063 YR METFORMIN| PLAVIX| ALPRAZOLAM| "PROPOXYPHNP-APAP"| ASPIRIN| GLYBURIDE| MULTIVITAMIN