BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 513 ANALYZER

    MDR report key: 23647686 · Received November 25, 2025

    Report

    Report Number
    1823260-2025-04843
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946327
    PMA / PMN Number
    K160571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 REAGENT LOT NUMBER WAS 872464. THE EXPIRATION DATE WAS NOT PROVIDED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS NO FURTHER ISSUES WERE REPORTED, AND A CORRECT RERUN WAS PERFORMED WITH THE SAME REAGENT. THE FIELD SERVICE ENGINEER FOUND THAT THE SAMPLE PROBE WAS OVERDUE FOR REPLACEMENT. HE REPLACED THE SAMPLE PROBE AND VERIFIED AND ADJUSTED THE GEAR PUMP PRESSURE. HE THEN CONFIRMED THAT THE INSTRUMENT AND THE TEST WERE PERFORMING WITHIN SPECIFICATIONS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FOR 1 PATIENT SAMPLE TESTED ON THE COBAS C 513 ANALYZER. INITIAL RESULT: 52.2 %. ON (B)(6) 2025: REPEAT RESULT: 4.9 % (TESTED ON A VARIANT SYSTEM). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619766 COBAS C 513 ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630946327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown