BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT

    MDR report key: 2114520 · Received June 6, 2011

    Report

    Report Number
    1823260-2011-03017
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K003178
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO ROOT-CAUSE COULD BE DETERMINED. A POSSIBLE REASON FOR THE EVENT WAS THE CUSTOMER NOT USING THE RECOMMENDED RACK ADAPTERS. THE PATIENT WAS NOT ADVERSELY AFFECTED AND WAS DISCHARGED IN GOOD CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR HCG+B ON THEIR COBAS E601 ANALYZER (SERIAL NUMBER (B)(4)).THE PHYSICIAN RECEIVED THE REPORT AND QUESTIONED IT DUE TO THE PRESENCE OF A STRONG FETAL HEARTBEAT. REPEAT TESTING WAS PERFORMED ON THE SAME E601 ANALYZER. THE INITIAL HCG+B RESULT WAS 0.296 MIU/ML. THE FIRST REPEAT RESULT WAS 100485 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS AUTO-DILUTED BY THE ANALYZER AND REPEATED WITH NO SPECIFIC DATA PROVIDED. THE SECOND REPEAT RESULT WAS 104992 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS AUTO-DILUTED AND REPEATED WITH NO SPECIFIC DATA PROVIDED. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CUSTOMER WAS NOT USING TUBE ADAPTORS ON PATIENT SAMPLE RACK WHICH RESULTED IN THE TUBES SHIFTING IN THE RACK. THE SHIFTING OF THE TUBES IN THE RACK CAN CAUSE ERRATIC RESULTS DUE TO PREMATURE DETECTING OF THE SAMPLES. HE COMMUNICATED TO THE CUSTOMER TO MAKE SURE TO USE THE TUBE ADAPTORS AS RECOMMENDED IN PRODUCT LABELING. HE RAN PERFORMANCE TESTING WITH PASSING RESULTS. THE CUSTOMER CALIBRATED AND PERFORMED QUALITY CONTROL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 025 YR