BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3090356 · Received May 2, 2013

    Report

    Report Number
    1823260-2013-02706
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MZP
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES WERE INVESTIGATED AND WERE FOUND TO BE NEGATIVE ON TWO DIFFERENT IMMUNOASSAY MANUFACTURERS' METHODS. NO ADDITIONAL SAMPLE WAS AVAILABLE FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ANTIBODY TO (B)(6) RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER PROVIDED DATA FOR TWO PATIENTS, ONE OF WHICH HAD DISCREPANT RESULTS. THE SPECIFIC DATE OF THIS EVENT WAS NOT KNOWN. THE PATIENT'S INITIAL (B)(6) RESULT WAS (B)(6) AND IT WAS INTERPRETED AS (B)(6). THE SAMPLE WAS REPEATED USING THE LUMIPULSE F (FUJIREBIO) METHOD. THE REPEAT RESULT WAS (B)(6) AND IT WAS INTERPRETED AS (B)(6). IT WAS UNKNOWN IF EITHER RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE AHCV REAGENT LOT NUMBER AND EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191162 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER MZP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1