BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2

    MDR report key: 23657165 · Received November 26, 2025

    Report

    Report Number
    1823260-2025-04867
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    February 2, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJE
    UDI-DI
    04015630919505
    PMA / PMN Number
    K033185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 CALIBRATION RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE QC RECOVERY DATA FOR THE AFFECTED ASSAYS WAS HIGH BUT WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER. NEW ROCHE QC WAS ORDERED AND PERFORMED BY THE CUSTOMER WITH ADJUSTED MEANS. QC WAS PERFORMED WITHIN SPECIFICATION. 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 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THIS MEDWATCH WILL COVER ALP. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CALCIUM RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LACTATE RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDH RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AST RESULTS. THE DOCTOR QUESTIONED THE RESULTS AS THEY WERE HIGH AND DID NOT MATCH THE CLINICAL STATUS OF OUTPATIENTS IN "NORMAL" CONDITION. NO SPECIFIC SAMPLE RESULTS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948422 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES CJE ROCHE DIAGNOSTICS 88236001 04015630919505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown