BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT COMPLEMENT C3C TEST SYSTEM

    MDR report key: 18760036 · Received February 22, 2024

    Report

    Report Number
    1823260-2024-00524
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    January 20, 2024
    Report Date
    April 8, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CZW
    PMA / PMN Number
    K012361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE ALARM TRACE SHOWED 36 ABNORMAL ASPIRATION ALARMS. BLOOD WAS VISIBLE IN THE GEL LAYER OF THE SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE C3C-2 TINA-QUANT COMPLEMENT C3C VER.2 AND C4-2 TINA-QUANT COMPLEMENT C4 VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER C3C. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE C4 RESULTS. ON (B)(6) 2024, THE INITIAL C3C RESULT WAS 62.6 MG/DL. THE DOCTOR QUESTIONED THE RESULTS AND THE SAMPLE WAS REPEATED. ON (B)(6) 2024, THE SAMPLE WAS REPEATED AND THE REPEAT C3C RESULT WAS 104 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444994 TINA-QUANT COMPLEMENT C3C TEST SYSTEM COMPLEMENT C3 TEST CZW ROCHE DIAGNOSTICS 64986301

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female