BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALP2 ALP IFCC GEN.2

    MDR report key: 19840717 · Received July 26, 2024

    Report

    Report Number
    1823260-2024-02175
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJE
    UDI-DI
    04015630919512
    PMA / PMN Number
    K033185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 AND UREAL UREA/BUN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THIS MEDWATCH WILL COVER ALP2. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-00070199 FOR INFORMATION ON THE UREA RESULTS. FOR SAMPLE 1, THE INITIAL ALP RESULT WAS 9 U/L. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 144 U/L. FOR SAMPLE 2, THE INITIAL UREA RESULT WAS 0.5 MMOL/L. THE RESULT WAS LOWER THAN THE MEASURING RANGE WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 11.6 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922739 ALP2 ALP IFCC GEN.2 NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES CJE ROCHE DIAGNOSTICS ASKU 04015630919512

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown