BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 8536315 · Received April 22, 2019

    Report

    Report Number
    3011393376-2019-01504
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    April 1, 2019
    Report Date
    June 1, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES WITH SYSTEM 1: LO MG/DL (WHICH ON THE SYSTEM INDICATES A RESULT OF LESS THAN 20 MG/DL) AND "160'S" MG/DL. IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES WITH SYSTEM 2: LO MG/DL (WHICH ON THE SYSTEM INDICATES A RESULT OF LESS THAN 20 MG/DL), LO MG/DL, LO MG/DL, AND 402 MG/DL. ALL READINGS OCCURRED WITH THE SAME VIAL OF TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330978 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 100921

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR