BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION

    MDR report key: 21854485 · Received April 17, 2025

    Report

    Report Number
    1823260-2025-01172
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 15, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIT
    UDI-DI
    04015630920549
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS 4000 C311 STAND ALONE SYSTEM SERIAL NUMBER IS (B)(6). A FIELD SERVICE ENGINEER (FSE) RAN PROBE WASHES AND VERIFIED THE GEAR PUMP PRESSURE WAS WITHIN RANGE. THE FSE CHECKED PROBES, WASHING, AND RINSE MECHANISM LEVELS. THEY RAN ROCHE QC'S AND BIORAD QC'S FOR THE AST. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE ALARM TRACE DID NOT CONTAIN ANY CONSPICUOUS EVENTS. THE ROCHE QC WAS PASSING BEFORE THE EVENT. THE BIORAD QC WAS WITHIN RANGE ON THE DAY OF THE EVENT BUT OUT OF RANGE ON (B)(6) 2025. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. HOWEVER, THE INSTRUMENT WAS VERIFIED, AND THE ISSUE APPEARS TO BE RESOLVED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ASTL/PYP RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. PATIENT 1'S INITIAL RESULT WAS 12.9 U/L, AND THE REPEAT RESULTS OF 20.3 U/L AND 21.7 U/L WITH A NEW CALIBRATION LOT ON 27-MAR-2025. PATIENT 2'S INITIAL RESULT WAS 16.2 U/L, AND THE REPEAT RESULTS OF 22.6 U/L AND 19.5 U/L WITH A NEW CALIBRATION LOT ON 27-MAR-2025. THE RESULT OF 22.6 U/L FOR PATIENT 2 WAS DEEMED TO BE CORRECT. THE CUSTOMER DISCOVERED THE QUESTIONABLE RESULTS DURING METHOD COMPARISON TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763827 ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM CIT ROCHE DIAGNOSTICS 79982801 04015630920549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown