BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 8578025 · Received May 3, 2019

    Report

    Report Number
    3011393376-2019-01659
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 22, 2019
    Report Date
    September 5, 2019
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES: 10.0 MMOL/L, 31.5 MMOL/L, "HI" MMOL/L (GREATER THAN 33.3 MMOL/L), AND 17.5 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371563 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 476800

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR