BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTACT HUMAN CHORIONIC GONADOTROPIN + THE BETA-SUBUNIT

    MDR report key: 2111869 · Received June 2, 2011

    Report

    Report Number
    1823260-2011-02964
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 7, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED WITH THE INFORMATION PROVIDED FOR INVESTIGATION. ANALYSIS OF THE INSTRUMENT AND CALIBRATION DATA VERIFIED THEY WERE ACCEPTABLE AND DID NOT INDICATE A GENERAL ASSAY OR INSTRUMENT PROBLEM. THERE WAS ALSO NO INDICATION OF A PREANALYTIC PROBLEM. THE PATIENT WAS NOT TREATED BASED ON INITIAL RESULTS.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE LOW HCG + SS RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS 6000 E601 ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT FROM AN ALIQUOT TUBE CREATED BY THE MPA (MODULAR PREANALYTIC ANALYZER) WAS 1.48 MIU/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE HE KNEW THE PATIENT WAS ACTUALLY PREGNANT AND EXPECTED HIGHER RESULTS. THE PRIMARY SAMPLE TUBE FOR THIS PATIENT WAS THEN TESTED AND THE RESULT WAS 189.2 MIU/ML. THE USER THEN POURED THE SAMPLE FROM THE ORIGINAL ALIQUOT TUBE INTO A SAMPLE CUP AND REPEATED TESTING WITH A RESULT OF 185.8 MIU/ML. THE USER STATED THEY REPORTED THE RESULT OF 189.2 MIU/ML SINCE THE TWO REPEAT RESULTS MATCHED. THE PATIENT WAS NOT ADVERSELY AFFECTED AND WAS NOT TREATED BASED ON THE INITIAL RESULT. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A SAMPLE LEVEL DETECTION PIPETTING ERROR. HE CHECKED THE ANALYZER, PROBE VOLTAGE AND PROBE ALIGNMENT. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING AND SYSTEM DIAGNOSTICS. HE DETERMINED THE ANALYZER WAS PERFORMING ACCORDING THE SPECIFICATIONS. THE USER SUCCESSFULLY RAN QUALITY CONTROL.

    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 16015003

    Patients

    Seq Age Sex Outcome Treatment
    1