BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 5352842 · Received January 8, 2016

    Report

    Report Number
    3011393376-2016-00110
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 3, 2015
    Report Date
    February 23, 2018
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES AND ON THREE DIFFERENT DAYS: ON (B)(6) 2015, 25 MG/DL AND 122 MG/DL, ON (B)(6) 2015 30 MG/DL AND 124 MG/DL, AND ON (B)(6) 2015 33 MG/DL AND 147 MG/DL. DRUM VIAL HAS BEEN DISCARDED. NO ADVERSE EVENT REPORTED. METER WILL BE RETURNED; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11925 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR