BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT ANTISTREPTOLYSIN O

    MDR report key: 21833077 · Received April 14, 2025

    Report

    Report Number
    1823260-2025-01121
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 20, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GTQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 4000 C311 STAND ALONE SYSTEM IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RECEIVED A NEW QUESTIONABLE TINA-QUANT ANTISTREPTOLYSIN O ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. ON (B)(6) 2025: THE INITIAL RESULT FROM THE ANALYZER WAS 622 U/L. THE REPEAT RESULT FROM AN EXTERNAL LABORATORY WAS 455 U/L. THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND DID NOT FIND ANY ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM BASED ON THE INFORMATION PROVIDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ON THE FIELD SERVICE ENGINEER'S SERVICE VISIT, HE ALSO REPLACED THE SAMPLE PROBE AS A PROACTIVE MEASURE AND CALIBRATED THE WASH STATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT ANTISTREPTOLYSIN O ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL RESULT FROM THE ANALYZER WAS 397 IU/ML, AND WAS CONFIRMED BY RERUNS. THE FIRST REPEAT RESULT FROM ANOTHER LABORATORY'S POLYMERASE CHAIN REACTION (PCR) ASSAY WAS 0.41 MG/L. THE SECOND REPEAT RESULT FROM ANOTHER LABORATORY'S ANALYZER WITH A SIMILAR LABORATORY METHOD TO THE REPORTED ASSAY WAS 276 U/L. THE INITIAL AND SECOND REPEAT RESULTS HAD THE SAME CLINICAL INTERPRETATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2349669 TINA-QUANT ANTISTREPTOLYSIN O ANTISTREPTOLYSIN - STREPTOLYSIN O REAGENT GTQ ROCHE DIAGNOSTICS 82332701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown