BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3162616 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03501
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED WITH THE PROVIDED INFORMATION. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN RANGE AND A GENERAL REAGENT ISSUE WAS NOT FOUND. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S CENTRIFUGATION SPECIFICATIONS. THE SERVICE CHECKS DEMONSTRATED THE ANALYZER WAS WORKING AND THERE WAS NO EVIDENCE FOR AN INSTRUMENT RELATED PROBLEM.

    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 E601 ANALYZER. THE PATIENT'S SAMPLES WERE DRAWN IN THE EMERGENCY ROOM. THE PATIENT'S INITIAL HCGB RESULT FROM A PLASMA SAMPLE TESTED IN THE PRIMARY TUBE WAS 0.1 MIU/ML ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. IT WAS THE CUSTOMER'S UNDERSTANDING THAT THE PATIENT WAS PREGNANT. THE CUSTOMER PERFORMED A QUICK PREGNANCY TEST USING A SEKISUI DIAGNOSTICS PREGNANCY SCREENING TEST AND THE RESULT WAS POSITIVE. BASED ON THE POSITIVE RESULTS AND PRESUMED PREGNANCY, A SERUM SAMPLE IN AN ALIQUOT TUBE DRAWN AT THE SAME TIME AS THE INITIAL PLASMA WAS TESTED IN THE SAME E601 ANALYZER. THE SAMPLE WAS DILUTED 1:100, AND THE RESULT WAS 78.73 MIU/ML. THE SERUM SAMPLE WAS THEN TESTED UNDILUTED AND THE RESULT WAS 123.8 MIU/ML. THE RESULT OF 123.8 MIU/ML WAS CONSIDERED CORRECT AND REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 16956305 AND THE EXPIRATION DATE WAS 01/31/2014. THE FIELD SERVICE REPRESENTATIVE NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED RACK ADAPTORS. HE REPEATED THE SAMPLE USING THE CORRECT TUBE CONFIGURATION AND NO MORE ERRONEOUS RESULTS WERE PRODUCED. THE ANALYZER MET SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263357 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR