BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ADVANTAGE TEST STRIPS

    MDR report key: 2802755 · Received October 24, 2012

    Report

    Report Number
    1823260-2012-05353
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 11, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. MEDWATCH WITH (B)(6) IS FOR ADVANTAGE / SENSOR SYSTEM 1, MEDWATCH WITH (B)(6) IS FOR ADVANTAGE / SENSOR SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 198 MG/DL USING ADVANTAGE / SENSOR SYSTEM 1 AND 101 MG/DL USING ADVANTAGE / SENSOR SYSTEM 2 WITHIN 10 MINUTES. 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
    1 ACCU-CHEK ® ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 571757

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR