BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTP

    MDR report key: 17250596 · Received July 3, 2023

    Report

    Report Number
    1823260-2023-02160
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 24, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIT
    UDI-DI
    07613336121023
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE C503 ANALYZER SERIAL NUMBER WAS (B)(6). THE CUSTOMER NOTED THAT THE ASSAY USED WITH THE C503 ANALYZER USES PYRIDOXAL PHOSPHATE (PYP) ACTIVATION WHEREAS THE ASSAY USED WITH THE DXC 700 AU ANALYZER DOES NOT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE, THEREFORE, A GENERAL REAGENT OR INSTRUMENT ISSUE IS NOT SUSPECTED. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH TWO DIFFERENT TESTS (ONE WITH PYRIDOXAL PHOSPHATE (PYP) ACTIVATION AND ONE WITHOUT PYP) BEING USED TO TEST THE PATIENT SAMPLE. ASSAYS WITH PYP SHOW HIGHER RESULTS COMPARED TO ASSAYS WITHOUT PYP. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (ASTP) ON A COBAS PRO C 503 ANALYTICAL UNIT COMPARED TO A DXC 700 AU ANALYZER. THE RESULT FROM THE C503 ANALYZER WAS 385 U/L. THE RESULT FROM A DXC 700 AU ANALYZER WAS 181.99 U/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19990 ASTP NADH OXIDATION/NAD REDUCTION, AST/SGOT CIT ROCHE DIAGNOSTICS NA 70098801 07613336121023

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown