BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBUMIN BCP

    MDR report key: 18305588 · Received December 11, 2023

    Report

    Report Number
    1823260-2023-03938
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 16, 2023
    Report Date
    December 11, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJW
    UDI-DI
    07613336121528
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ALBP EXPIRATION DATE WAS NOT PROVIDED. THE TP2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE COBAS PRO C503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE ALARM TRACE SHOWED ABNORMAL ASPIRATION ALARMS. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND FOUND NO ISSUES WITH THE ANALYZER. THE FSE REPLACED THE SAMPLE PROBE. THE CUSTOMER HAD NO FURTHER ISSUES AFTER THE SAMPLE PROBE WAS REPLACED. THE ROOT CAUSE WAS CONSISTENT WITH A PRE-ANALYTICAL ISSUE.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH TOTAL PROTEIN GEN.2 (TP2) ASSAY AND ALBUMIN BCP (ALBP) ASSAY ON A COBAS PRO C503 ANALYZER. THIS MEDWATCH WILL APPLY TO THE ALBP ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6). FOR INFORMATION RELATED TO THE TP2 ASSAY. ALBP: INITIAL RESULT: 4.83 G/L. REPEAT RESULT: 42.4 G/L. TP2: INITIAL RESULT: 5.60 G/L. REPEAT RESULT: 75.3 G/L. THE MEDICAL PERSONNEL QUESTIONED THE RESULTS AND THE SAMPLE WAS THEN REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694467 ALBUMIN BCP ALBUMIN BROMCRESOL PURPLE DYE-BINDING METHOD CJW ROCHE DIAGNOSTICS ASKU 07613336121528

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown