BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK PERFORMA TEST STRIPS

    MDR report key: 11662814 · Received April 14, 2021

    Report

    Report Number
    3011393376-2021-01194
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 24, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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 ON (B)(6) 2021: 32 MG/DL AND 215 MG/DL. IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2021: 118 MG/DL AND 577 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561286 ACCU-CHEK PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 479197

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR APIDRA INSULIN| LANTUS INSULIN| APIDRA INSULIN| LANTUS INSULIN