BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

    MDR report key: 23223466 · Received October 6, 2025

    Report

    Report Number
    1823260-2025-04069
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 9, 2025
    Report Date
    November 4, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJE
    PMA / PMN Number
    K033185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE EVENT AND DETERMINED THAT THE CAUSE WAS A CONTAMINATED PATIENT SAMPLE. THE FSE VERIFIED ANALYZER PERFORMANCE VIA SUCCESSFUL PRECISION CHECKS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE CALIBRATION DATA, AND THE RESULTS WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 162 U/L. THE FIRST REPEAT RESULT FROM THE OTHER COBAS LINE WAS 334 U/L. THE SECOND REPEAT RESULT FROM THE OTHER COBAS LINE WAS 360 U/L. THIS RESULT WAS DEEMED CORRECT AND REPORTED. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY DUE TO DATA FLAGS ON OTHER ASSAYS, PROMPTING THE RERUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343602 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES CJE ROCHE DIAGNOSTICS 86942501

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male