BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION

    MDR report key: 20205614 · Received September 12, 2024

    Report

    Report Number
    1823260-2024-02645
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    March 1, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKA
    UDI-DI
    04015630928927
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. THE AST RESULTS WERE CONSIDERED TO BE ELEVATED WHICH MAY BE RELATED TO THE HEART DISEASE MENTIONED (THE PATIENT HAS ELEVATED CLINICAL HEART MARKER RESULTS). THE "NORMAL" ALT RESULTS ARE MOST LIKELY CORRECT. NO DATA WAS PROVIDED THAT WOULD INDICATE THE ALT RESULTS WERE "FALSE NORMAL" OR TOO LOW. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE 2 OTHER METHODS WERE ORTHO AND HITACHI. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR 3 SAMPLES FROM 1 PATIENT TESTED FOR ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALT) ON A COBAS 8000 C 702 MODULE. THE PATIENT HAD A LIVER TRANSPLANT IN (B)(6) 2024. FOLLOWING THE TRANSPLANT, THE PATIENT WAS TESTED FOR ALT "MULTIPLE TIMES" BY 2 OTHER METHODS AND THE RESULTS WERE ALL "NORMAL" BUT THE AST RESULTS WERE ELEVATED. THE C702 MODULE WAS INSTALLED AT THE CUSTOMER SITE IN (B)(6) 2024. THE CUSTOMER RAN THE SAMPLES THAT WERE DRAWN IN (B)(6) 2024 ON THE C702 MODULE AND THE RESULTS WERE CONSISTENT WITH THE ALT RESULTS FROM THE OTHER METHODS. THE CUSTOMER SUSPECTS AN INTERFERENCE AS THE PATIENT¿S AST RESULTS WERE HIGH BUT THE ALT RESULTS WERE "NORMAL." NOTE: THE UNIT OF MEASURE WAS NOT PROVIDED. SAMPLE 1: THE INITIAL RESULT WAS 34.9. THE RESULT FROM A 1:10 DILUTION WAS 27.5. THE ALTLP RESULT WAS 44.4. SAMPLE 2: THE INITIAL RESULT WAS 35.9. THE RESULT FROM A 1:10 DILUTION WAS 30.8. THE ALTLP RESULT WAS 47.1. SAMPLE 3: THE INITIAL RESULT WAS 36.4. THE RESULT FROM A 1:10 DILUTION WAS 29.4. THE ALTLP RESULT WAS 44.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505509 ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION NADH OXIDATION/NAD REDUCTION, ALT/SGPT CKA ROCHE DIAGNOSTICS 743176 04015630928927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown