BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3090473 · Received May 2, 2013

    Report

    Report Number
    1823260-2013-02715
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE PATIENT HAS RETURNED TO THE DOCTOR'S OFFICE SINCE THIS EVENT AND WAS NOT PREGNANT.

    Additional Manufacturer Narrative · 1

    THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN RANGE AND A REAGENT ISSUE WAS NOT LIKELY. THERE WAS NO EVIDENCE OF AN INSTRUMENT RELATED PROBLEM. THE ELECSYS RESULT WAS DEEMED TO BE CORRECT AS THE PATIENT WAS NOT PREGNANT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS FOR ONE PATIENT ON THEIR E- MODULE. THE PATIENT'S INITIAL HCGB RESULT WAS 0.100 IU/ML ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.100 IU/ML ACCOMPANIED BY A DATA FLAG. THE PATIENT WAS CONFIRMED TO BE FIVE WEEKS PREGNANT BY AN ULTRASOUND. THE SAMPLE WAS SENT TO ANOTHER LABORATORY TO BE TESTED USING AN UNKNOWN METHOD. ON (B)(6) 2013, THE RESULT WAS <1 IU/L. THE CUSTOMER DID NOT KNOW WHAT RESULTS WERE CORRECT. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 16956305 AND THE EXPIRATION DATE WAS 01/31/2014. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE TESTED THE SAMPLE FROM THE MASTER TUBE AND FROM A POUR OFF SAMPLE AND RECEIVED RESULTS OF 0.1 IU/ML. HE CONFIRMED THE SAMPLE AND REAGENT ALIGNMENTS AND DISPENSE. ALL CHECKS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191769 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 041 YR