BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 4162013 · Received October 10, 2014

    Report

    Report Number
    1823260-2014-07786
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    November 3, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON AVAILABLE DATA. A GENERAL REAGENT ISSUE OR INSTRUMENT PROBLEM SEEMS UNLIKELY BASED ON AVAILABLE DATA. ADDITIONAL INFORMATION FOR INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. FIELD SERVICE PERSONNEL VISITED THE SITE AND INDICATED THE INSTRUMENT WAS OK. HE CHANGED THE SAMPLE PIPETTE AND PERFORMED GENERAL INSTRUMENT CHECKS. INSTRUMENT PERFORMANCE TESTS PASSED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    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 498.60 UI/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN ORDERED A NEW TEST. ON (B)(6) 2014, THE PATIENT HAD ANOTHER SAMPLE TESTED AND THE HCGB RESULT WAS 0.100 UI/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.100 UI/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE FIRST SAMPLE WAS REPEATED ON (B)(6) 2014, AND THE RESULT WAS 0.388 UI/ML. THE CUSTOMER THEN FOUND A THIRD SAMPLE FROM THIS PATIENT TO TEST AND THE RESULT WAS 0.426 UI/ML. ON (B)(6) 2014, THE THREE SAMPLES WERE THEN TESTED IN ANOTHER LABORATORY WITH SIMILAR RESULTS. THE RESULTS FROM THE FIRST SAMPLE WAS 0.583 UI/ML ACCOMPANIED BY A DATA FLAG AND 0.476 UI/ML ACCOMPANIED BY A DATA FLAG. THE RESULT FROM THE SECOND SAMPLE WAS 0.100 UI/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER STATED THE FIRST SAMPLE WAS ALSO TESTED IN ANOTHER LABORATORY WITH A COBAS 8000 E602 ANALYZER. THE RESULTS WAS 0.398 UI/ML AND 0.382 UI/ML BOTH ACCOMPANIED BY DATA FLAGS. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 177537 AND THE EXPIRATION DATE WAS 08/31/2015. THE FIELD SERVICE REPRESENTATIVE INSPECTED THE ANALYZER. HE CHANGED THE SAMPLE PIPETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644550 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR