BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 3790456 · Received May 5, 2014

    Report

    Report Number
    1823260-2014-03189
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    June 12, 2014
    Manufacturer
    NA
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 86 MG/DL, 335 MG/DL AND 148 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267943 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR NA NA 20809253

    Patients

    Seq Age Sex Outcome Treatment
    1 068 YR NOVOLOG| LANTUS