BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTACT HUMAN CHORIONIC GONADOTROPIN + THE BETA-SUBUNIT

    MDR report key: 2091734 · Received May 17, 2011

    Report

    Report Number
    1823260-2011-02616
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 29, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATION. NO REAGENT ISSUE WAS IDENTIFIED. THE RACK USED FOR INITIAL TESTING WAS NOT EQUIPPED WITH A REQUIRED RACK ADAPTER. THIS IS A POSSIBLE CAUSE FOR THIS EVENT. THE PATIENT WAS NOT AFFECTED BY THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HCG+BETA II (HCG) RESULTS FOR ONE PATIENT WHEN TESTED ON A COBAS 6000 E601 MODULE, SERIAL NUMBER (B)(4). ALL TESTING WAS PERFORMED ON THE SAME ANALYZER. SAMPLE 1, INITIAL RESULT WAS 3.35 MIU/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THIS SAMPLE WAS REPEATED TWICE AND RECOVERED 10000 MIU/ML (ACCOMPANIED BY A DATA FLAG) BOTH TIMES. A SECOND SAMPLE WAS DRAWN FROM THE PATIENT ON (B)(6) 2011. SAMPLE 2, INITIAL RESULT WAS 10000 MIU/ML (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED AND RECOVERED 75332 MIU/ML (WHEN AUTO DILUTED BY THE ANALYZER). A CORRECTED REPORT WAS GENERATED REPORTING THE 75332 MIU/ML RESULT TO THE PHYSICIAN. SAMPLE 1 WAS RETESTED TWICE ON (B)(6) 2011 AND GENERATED 10000 MIU/ML (ACCOMPANIED BY A DATA FLAG) BOTH TIMES. THE PATIENT WAS NOT TREATED OR HARMED IN ANY WAY BASED ON THE ERRONEOUS RESULT OF 3.35 MIU/ML. THE FIELD SERVICE REPRESENTATIVE DETERMINED SAMPLE 1 WAS A 7 ML TUBE AND WAS FIRST RUN WITHOUT USING A RACK TUBE INSERT. WHEN THE RERUN WAS PERFORMED USING THE INSERT, THE RESULT WAS OK. THE FIELD SERVICE REPRESENTATIVE INFORMED THE CUSTOMER THAT THE TUBE WIDTH SHOULD ALWAYS MATCH THE RACK BEING USED AND TO USE INSERTS WHEN NEEDED. HE REPEATED SAMPLE 1 USING THE PROPER INSERT WHICH RECOVERED 72249 MIU/ML AND 72825 MIU/ML (BOTH WITH AUTO DILUTION). CALIBRATION AND QUALITY CONTROL WERE RUN WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTACT HUMAN CHORIONIC GONADOTROPIN + THE BETA-SUBUNIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS NA 16015006

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR