BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION

    MDR report key: 4846629 · Received June 16, 2015

    Report

    Report Number
    1823260-2015-03640
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    April 6, 2015
    Report Date
    August 4, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIT
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE PROVIDED DATA, IT WAS DETERMINED THE TEST MEASURED THE CORRECT AMOUNT OF AST IN THE PATIENT SAMPLE WHICH WAS ELEVATED DUE TO POSSIBLE MACRO ENZYMES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ASPARTATE AMINOTRANSFERASE (AST) RESULTS FOR ONE PATIENT FROM A COBAS C501. (B)(6) 2015: 311 U/L 02/21/2015: 551 U/L 10/09/2013: 291 U/L IT WAS UNCERTAIN IF THESE RESULTS WERE GENERATED FROM THE SAME PATIENT SAMPLE. WITH THE SAMPLE THAT GENERATED THE RESULT OF 311 U/L, THE CUSTOMER PERFORMED PRECIPITATION WITH PEG5000: SAMPLE WITH PEG5000 25% IN PBS (1)- <10 U/L SAMPLE WITH PEG5000 25% IN PBS (2)- <10 U/L %PPA 96.8% (PPA REF 18-53 %). THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER SUSPECTED THE PRESENCE OF A MACROENZYME, ONE COMPLEXED WITH AN IMMUNOGLOBULIN AND AST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390690 ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION NADH OXIDATION/NAD REDUCTION, AST/SGOT CIT ROCHE DIAGNOSTICS NA 61168

    Patients

    Seq Age Sex Outcome Treatment
    1 025 YR