BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ADVANTAGE TEST STRIPS

    MDR report key: 3024250 · Received March 27, 2013

    Report

    Report Number
    1823260-2013-01878
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    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

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM COMPARED TO LAB RESULTS WITHIN 10 MINUTES: 230 MG/DL (METER) AND 90 MG/DL (LAB). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126857 ACCU-CHEK ® ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 571755

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR