BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 9803308 · Received March 6, 2020

    Report

    Report Number
    3011393376-2020-00846
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Date of Event
    January 25, 2020
    Report Date
    May 21, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702438101
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: (B)(6) 2020: HI MG/DL ON AT 10:56PM, 77 MG/DL AT 10:58PM; (B)(6) 2020: 229 MG/DL AT 11:00AM 87, MG/DL AT 11:04AM; (B)(6) 2020: 210 MG/DL AT 12:10AM, 88 MG/DL AT 12:12AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266651 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 06908349001 498543 00365702438101

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR