BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTP

    MDR report key: 18798188 · Received February 28, 2024

    Report

    Report Number
    1823260-2024-00580
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    January 16, 2024
    Report Date
    May 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIT
    UDI-DI
    07613336121023
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH THE COMPARISON OF RESULTS PRODUCED FROM REAGENTS USING PYRIDOXAL PHOSPHATE (PYP) ACTIVATION ON THE PURE C 303 AND WITHOUT PYP ACTIVATION ON THE COBAS INTEGRA. LIVER DISEASES CAN BE ASSOCIATED WITH PYP DEFICIENCY AND INCREASED TRANSAMINASE RESULTS WHICH ARE NOT PROPERLY DETECTED WITH NON ACTIVATING TESTS. PER PRODUCT LABELING, "PYRIDOXAL PHOSPHATE ACTIVATION PREVENTS FALSELY LOW AMINOTRANSFERASE ACTIVITY IN PATIENT SAMPLES WITH INSUFFICIENT ENDOGENOUS PYRIDOXAL PHOSPHATE (VITAMIN B6 DEFICIENCY). " THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ASTPM ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 2 PATIENT SAMPLES ON A COBAS PURE C 303 ANALYTICAL UNIT. FOR SAMPLE 1, THE INITIAL AST RESULT WAS 70.7 U/L. THE SAMPLE WAS REPEATED ON A COBAS INTEGRA ANALYZER AND THE REPEAT RESULT WAS 45.7 U/L. FOR SAMPLE 2, THE INITIAL AST RESULT WAS 75.0 U/L. THE SAMPLE WAS REPEATED ON A COBAS INTEGRA ANALYZER AND THE REPEAT RESULT WAS 35.7 U/L. THE EXACT DATES OF TESTING FOR SAMPLE 2 WERE NOT PROVIDED. THE COBAS INTEGRA RESULTS WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931835 ASTP NADH OXIDATION/NAD REDUCTION, AST/SGOT CIT ROCHE DIAGNOSTICS 75268601 07613336121023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown