BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 14375961 · Received May 12, 2022

    Report

    Report Number
    3011393376-2022-01439
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 29, 2022
    Report Date
    June 10, 2022
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702407107
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 134 MG/DL AT 10:50 AM ON (B)(6) 2022167 MG/DL AT 10:49 AM ON (B)(6) 2022216 MG/DL AT 10:48 AM ON (B)(6) 2022104 MG/DL AT 10:47 AM ON (B)(6) 2022

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114315 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 06908217001 690030 00365702407107

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female