BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTACT HUMAN CHORIONIC GONADOTROPIN + THE ?-SUBUNIT

    MDR report key: 2112744 · Received June 3, 2011

    Report

    Report Number
    1823260-2011-02991
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. CALIBRATION AND QUALITY CONTROL WERE WITHIN RANGE. ANALYZER PERFORMANCE CHECKS DID NOT INDICATE AN ISSUE. THE MESSAGE HISTORY FROM THE ANALYZER NOTED LIQUID LEVEL DETECTION ALARMS AROUND THE TIME OF THE EVENT. A LIQUID LEVEL DETECTION ISSUE MAY HAVE CONTRIBUTED TO THE EVENT. NO ADVERSE AFFECTS TO THE PATIENT WERE REPORTED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR HCG+BETA ON THEIR ELECSYS 2010 RACK ANALYZER (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED DATA FOR THREE PATIENTS, OF WHICH THERE WAS ONE DISCREPANT RESULT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED A CLIENT CALLED TO QUESTION THE RESULT, SO THEY REPEATED THE SAMPLE. THE REPEAT TESTING WAS PERFORMED ON (B)(6) 2011 USING THE SAME 2010 ANALYZER. THE PATIENT'S ORIGINAL SAMPLE WAS 0.504 MIU/ML. THE FIRST REPEAT RESULT WAS 1479 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SECOND REPEAT RESULT WAS 1458 MIU/ML ACCOMPANIED BY A DATA FLAG. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE THE CAUSE OF THE EVENT. HE CHECKED THE CONDITION, ALIGNMENT AND WASH STATION FUNCTION OF THE SAMPLE AND SIPPER PROBES. HE CHECKED THE CONDITION OF THE SAMPLE AND REAGENT SYRINGES AND SEALS. HE ALSO CHECKED ALL MECHANISM FUNCTIONS. NO ISSUES COULD BE FOUND WITH THE CONDITION OR FUNCTION OF THE ANALYZER AND THE ISSUE COULD NOT BE REPRODUCED. HE RAN PERFORMANCE TESTS WITH PASSING RESULTS. THE CUSTOMER'S QUALITY CONTROL WAS IN NORMAL RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTACT HUMAN CHORIONIC GONADOTROPIN + THE ?-SUBUNIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS NA 16015003

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR