BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2013390 · Received March 10, 2011

    Report

    Report Number
    1823260-2011-01317
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHI
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT II (HCG+BETA) RESULTS FOR ONE PATIENT SAMPLE. ALL INITIAL AND REPEAT TESTING WAS PERFORMED ON THE SAME COBAS E601 ANALYZER. THE INITIAL RESULT WAS <0.1 MIU/ML. THE CUSTOMER REPEATED THE SAMPLE DUE TO PAST ISSUES WITH HCG+BETA. THE CUSTOMER REPEATED THE SAMPLE MANUALLY AND GENERATED >10,000 MIU/ML. THE CUSTOMER REPEATED THE SAMPLE AGAIN AND RECOVERED >10,000 MIU/ML. THE SAMPLE THEN AUTO REPEATED WITH DILUTION AND RECOVERED 17,522 MIU/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE HCG+BETA REAGENT LOT NUMBER WAS 15851502. THE FIELD SERVICE REPRESENTATIVE DETERMINED A LIQUID LEVEL DETECTION PROBLEM WAS THE CAUSE OF THE DISCREPANCIES. HE REPLACED THE P-NOZZLE BOX ASSEMBLY AND PERFORMED PRESSURE SENSE AND LIQUID LEVEL DETECTION ADJUSTMENTS. HE ALSO PERFORMED PROBE ALIGNMENTS. THE FIELD SERVICE REPRESENTATIVE RAN PERFORMANCE TESTS WHICH WERE ACCEPTABLE. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WHICH WERE ALSO ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1