BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION

    MDR report key: 21960187 · Received May 5, 2025

    Report

    Report Number
    1823260-2025-01380
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 13, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCP
    UDI-DI
    04015630926275
    PMA / PMN Number
    K102914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS INTEGRA 400 PLUS W/O ISE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND DID NOT FIND ANY ISSUES. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION RESULT FROM THE COBAS INTEGRA 400 PLUS W/O ISE ANALYZER. THE INITIAL RESULT WAS 6.95 %. THE REPEAT RESULT WAS 5.75 % AND WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485681 TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION ASSAY, GLYCOSYLATED HEMOGLOBIN LCP ROCHE DIAGNOSTICS 77732101 04015630926275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown