BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 3842601 · Received June 2, 2014

    Report

    Report Number
    1823260-2014-03902
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(6).

    Description of Event or Problem · 1

    CALLER REPORTED SIMILAR BLOOD GLUCOSE RESULTS OF APPROXIMATELY 21 MG/DL AND 89 MG/DL WITHIN 10 MINUTES USING THE SAME STRIPS IN BOTH COMPACT PLUS SYSTEM 1 AND COMPACT PLUS SYSTEM 2. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320818 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20809056

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR ZETIA| ALLOPURINOL| TRICOR| VIAGRA| NOVOLOG| LANTUS| LOVASTATIN