BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBP ALBUMIN BCP

    MDR report key: 8483242 · Received April 4, 2019

    Report

    Report Number
    1823260-2019-01365
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    October 4, 2018
    Report Date
    April 4, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJW
    PMA / PMN Number
    K844426
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR ALBP ALBUMIN BCP (ALBP) ON A COBAS 8000 C 702 MODULE. PATIENT 1 INITIAL ALBP RESULT WAS 68 G/L. THE REPEAT RESULT WAS 43 G/L. PATIENT 2 INITIAL ALBP RESULT WAS 58 G/L. THE REPEAT RESULT WAS 40 G/L. PATIENT 3 INITIAL ALBP RESULT WAS 81 G/L. THE REPEAT RESULT WAS 43 G/L. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE C702 MODULE SERIAL NUMBER WAS (B)(4). THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND ADJUSTED THE SAMPLE PROBE AND RINSE UNIT. ONE OF THE SAMPLE PROBES WAS REPLACED BY THE CUSTOMER. THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION FOR INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274535 ALBP ALBUMIN BCP BROMCRESOL PURPLE DYE-BINDING, ALBUMIN CJW ROCHE DIAGNOSTICS ALB BCP 35651401

    Patients

    Seq Age Sex Outcome Treatment
    1