BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

    MDR report key: 23574313 · Received November 17, 2025

    Report

    Report Number
    1823260-2025-04671
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 24, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJE
    UDI-DI
    07613336120972
    PMA / PMN Number
    K033185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH SAMPLE CONTAMINATION WITH CELL DEBRIS THAT WERE NOT SUFFICIENTLY REMOVED PRIOR TO TESTING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 3 PATIENT SAMPLES ON TWO COBAS C 503 ANALYTICAL UNITS. SAMPLE 1 HAD AN INITIAL ALP RESULT OF 147 U/L FROM ANALYZER B. THE SAMPLE WAS REPEATED ON ANALYZER A AND THE RESULT WAS 272 U/L. THE SAMPLE WAS REPEATED AGAIN ON ANALYZER B AND THE RESULT WAS 103 U/L. SAMPLE 2 WAS TESTED TWICE ON ANALYZER A AND THE RESULTS WERE 123 U/L AND 529 U/L. CLARIFICATION ON WHICH RESULT WAS THE INITIAL AND WHICH WAS THE REPEAT WAS NOT PROVIDED. SAMPLE 3 WAS TESTED TWICE ON ANALYZER B AND THE RESULTS WERE 105 U/L AND 159 U/L. CLARIFICATION ON WHICH RESULT WAS THE INITIAL AND WHICH WAS THE REPEAT WAS NOT PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289745 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES CJE ROCHE DIAGNOSTICS 90750401 07613336120972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown