BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ACTIVE TEST STRIPS

    MDR report key: 4172273 · Received October 15, 2014

    Report

    Report Number
    1823260-2014-07921
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE ACTIVE SYSTEM WITHIN 2 MINUTES: 68 MG/DL AND 116 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION; HOWEVER, THE SUSPECT STRIPS HAVE BEEN DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655026 ACCU-CHEK ® ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR