BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT

    MDR report key: 2994267 · Received March 8, 2013

    Report

    Report Number
    1823260-2013-01385
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULT FOR ONE PATIENT ON THEIR COBAS 6000 E601 MODULE ANALYZER, SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL HCGB RESULT WAS 3667 MIU/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2013, THE CUSTOMER COULD NOT PRODUCE GOOD QUALITY CONTROL RESULTS. THE CUSTOMER DECIDED TO RE-CALIBRATE THE ANALYZER, BUT THE CALIBRATION FAILED. ON (B)(6) 2013, THE PATIENT COMPLAINED ABOUT THE INITIAL RESULT. THE CUSTOMER REPEATED THE SAMPLE ON AN ELECSYS 2010 ANALYZER, SERIAL NUMBER NOT PROVIDED, AND THE RESULT WAS AROUND 76000 MIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. ON THE DAY OF THE EVENT, THE CUSTOMER HAD TWO REAGENT PACKS ON-BOARD THE ANALYZER FROM THE SAME LOT WITH A VALID CALIBRATION. IN THE MORNING, THE CUSTOMER PERFORMED QUALITY CONTROL ON THE REAGENT PACK IN USE, BUT NOT ON THE STANDBY PACK. DURING THE ROUTINE RUNNING, THE FIRST REAGENT PACK WAS EMPTIED. THE ANALYZER THEN SWITCHED TO THE OTHER REAGENT PACK ON-BOARD THAT DID NOT HAVE QUALITY CONTROL PERFORMED ON IT TO ANALYZE THE PATIENT'S SAMPLE. THE FIELD SERVICE REPRESENTATIVE THEN FOUND THAT ALL THE MAGNETIC PARTICLES FROM THE REAGENT WERE ON THE CAP OF THE REAGENT PACK, SO THE REACTION WAS NOT POSSIBLE. HE CHANGED THE REAGENT PACK, CALIBRATED THE TEST WITH SUCCESS, AND PERFORMED QUALITY CONTROL WITH PASSING RESULTS. AS ALL FURTHER CALIBRATIONS WERE WITHIN RANGE AND THE REAGENT PACK AT THE TIME OF THE EVENT DID NOT HAVE QUALITY CONTROL PERFORMED ON IT, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE CUSTOMER WAS ADVISED TO PERFORM QUALITY CONTROL ON ALL REAGENT PACKS AS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99402 INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ROCHE DIAGNOSTICS NA 169563

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR