BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALP2 ALP IFCC GEN.2

    MDR report key: 17806551 · Received September 25, 2023

    Report

    Report Number
    1823260-2023-03079
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 31, 2023
    Report Date
    December 1, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJE
    UDI-DI
    04015630919512
    PMA / PMN Number
    K033185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDICAL DEVICE PROBLEM CODE WAS UPDATED. BASED ON THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE COBAS INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(6). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ALKALINE PHOSPHATASE GEN.2 (ALP2) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. SAMPLE 1: INITIAL RESULT: 275 U/L. RERUN RESULT: 74.14 U/L. SAMPLE 2: INITIAL RESULT: 265 U/L. RERUN RESULT: 67.98 U/L. SAMPLE 3: INITIAL RESULT: 308 U/L. RERUN RESULT: 80.26 U/L. SAMPLE 4: INITIAL RESULT: 250 U/L. RERUN RESULT: 64.58 U/L. THE PHYSICIAN QUESTIONED THE RESULTS AND THE SAMPLES WERE RERUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267287 ALP2 ALP IFCC GEN.2 NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES CJE ROCHE DIAGNOSTICS 724589 04015630919512

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown