BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 6084588 · Received November 7, 2016

    Report

    Report Number
    3011393376-2016-07111
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 15, 2016
    Report Date
    December 7, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CN-190777A IS LOT 24655261, CN-190777B IS LOT 24644134. THE EVENT OCCURRED OUTSIDE 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

    CALLER REPORTED A SEPARATE COMPARISON OF BLOOD GLUCOSE RESULTS OF 67 MG/DL ON ACTIVE METER 1, 116 MG/DL ON ACTIVE METER 2 WITHIN 10 MINUTES. PATIENT USED TWO DIFFERENT VIALS OF TEST STRIPS FOR BOTH TESTS PERFORMED, 24655261 AND 24644134. IT WAS NOT REPORTED WHICH RESULT WAS OBTAINED WITH WHICH LOT. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732799 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 24655261

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR