BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 7999325 · Received October 24, 2018

    Report

    Report Number
    3011393376-2018-04441
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 2, 2018
    Report Date
    March 5, 2019
    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

    Additional Manufacturer Narrative · 1

    THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (TEST STRIP LOT 100624), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (TEST STRIP LOT 100550).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE GUIDE SYSTEM WITHIN 10 MINUTES: 78 MG/DL (TEST STRIP LOT 100550), 74 MG/DL (TEST STRIP LOT 100550), AND 120 MG/DL (TEST STRIP LOT 100624) NO ADVERSE EVENT REPORTED. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842852 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 100624

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR