BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBUMIN BCP

    MDR report key: 23359666 · Received October 22, 2025

    Report

    Report Number
    1823260-2025-04294
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    June 11, 2024
    Report Date
    October 22, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJW
    UDI-DI
    04015630927562
    PMA / PMN Number
    K844426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE BALL BEARINGS OF THE SAMPLE PIPETTOR WERE WORN AND REPLACED IT. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ALBUMIN BCP RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE DOCTOR QUESTIONED THE LOW INITIAL RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE INITIAL RESULT WAS 1167 MG/DL. THE REPEAT RESULT WAS 4331 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222198 ALBUMIN BCP BROMCRESOL PURPLE DYE-BINDING, ALBUMIN CJW ROCHE DIAGNOSTICS 788349 04015630927562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown