BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTREND ® TEST STRIPS

    MDR report key: 3051329 · Received April 10, 2013

    Report

    Report Number
    1823260-2013-02199
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE ACCUTREND GCT SYSTEM (LOT NUMBER AND EXPIRATION DATE UNKNOWN). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE PERFORMA SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULT OF 346 MG/DL ON THE PERFORMA SYSTEM, AND A RESULT OF 103 MG/DL ON THE ACCUTREND GCT SYSTEM WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152898 ACCUTREND ® TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS CGA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female