BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK PERFORMA TEST STRIPS

    MDR report key: 10566438 · Received September 22, 2020

    Report

    Report Number
    3011393376-2020-03425
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 16, 2020
    Report Date
    January 7, 2021
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 15 MINUTES: 11,5 MMOL/L, HI (= HIGHER THAN THE MEASUREMENT RANGE OF THE METER), 21,6 MMOL/L AND 7,8 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030776 ACCU-CHEK PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 478478

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR METFORMIN 400G - 2 TABLETS IN EVENING.| NOVA MIX 30 - 2X/DAY.| METFORMIN 400G - 2 TABLETS IN EVENING.| NOVA MIX 30 - 2X/DAY.