BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ADVANTAGE TEST STRIPS

    MDR report key: 4170035 · Received October 14, 2014

    Report

    Report Number
    1823260-2014-07850
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 8, 2014
    Report Date
    December 12, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT RECEIVED THE FOLLOWING RESULTS ON ADVANTAGE SYSTEM COMPARED TO A PROFESSIONAL METER WITHIN 1 MINUTE: 226 MG/DL (ADVANTAGE SYSTEM) AND 113 MG/DL (PROFESSIONAL METER). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651328 ACCU-CHEK ® ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 452082

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR