BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 6692870 · Received July 7, 2017

    Report

    Report Number
    3011393376-2017-03914
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    June 8, 2017
    Report Date
    July 17, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    PMA / PMN Number
    K113614
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: ON (B)(6) 2017: 29 MG/DL AND 230 MG/DL. ON (B)(6) 2017: 66 MG/DL AND 147 MG/DL. NO ADVERSE EVENT REPORTED. CALLER DECLINED TO RETURN METER AND STRIPS; REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473444 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 20814671

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR