BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 513 ANALYZER

    MDR report key: 23019184 · Received September 10, 2025

    Report

    Report Number
    1823260-2025-02821
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    July 10, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946327
    PMA / PMN Number
    K160571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 REAGENT LOT NUMBER IS 801605, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE RESULT FROM 11-AUG-2025 OF 7.4% WAS DEEMED TO BE CORRECT. A FIELD SERVICE ENGINEER (FSE) CHECKED THE ANALYZER AND DID NOT REPORT ANY RELATED HARDWARE FINDINGS. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. THE CUSTOMER HAS NOT REPORTED ANY FURTHER ISSUES SINCE THE FSE'S SERVICE CHECKS, AND THE ISSUE IS CONSIDERED TO BE RESOLVED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM THE COBAS C 513 ANALYZER FOR ONE PATIENT. THE INITIAL RESULT WAS 3.4 %. THE LOW RESULT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE, AS THE PATIENT HAS NO HISTORY OF HEMOGLOBIN VARIANT/THALASSEMIA, AND HAD A CONSISTENT HBA1C RESULT OF ~7.4% IN THE PAST YEAR. A NEW SAMPLE WAS COLLECTED ON (B)(6) 2025, AND THE RESULT WAS 7.4% THE INITIAL SAMPLE WAS DISCARDED AND COULD NOT BE RERUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468752 COBAS C 513 ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630946327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown