BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 3070747 · Received April 22, 2013

    Report

    Report Number
    1823260-2013-02441
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE QUALITY CONTROL DATA WERE WITHIN RANGE. THERE WERE NO REAGENT ISSUES EVIDENT. THE PERFORMANCE CHECK DATA WAS WITHIN SPECIFICATION ONE WEEK PRIOR TO THE EVENT. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE CLOTTING TIME RECOMMENDED BY THE TUBE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE ESTRADIOL (E2) AND PROGESTERONE RESULTS FOR ONE PATIENT ON THEIR ELECSYS 2010 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT E2 RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THE PATIENT'S SAMPLE APPEARED CLEAN AND CLEAR EVEN THOUGH THE CLOTTING TIME WAS NOT COMPLIANT WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. THE CUSTOMER CLAIMED THERE WERE NO BUBBLES OR CLOTS IN THE SAMPLE. IT WAS NOTED THE CUSTOMER HAD NOT CALIBRATED THESE ASSAYS IN QUITE SOME TIME AND THE CUSTOMER WAS RECOMMENDED TO GENERATE A NEW LOT CALIBRATION. ALL REPEAT TESTING WAS PERFORMED FROM THE PRIMARY TUBE. THE PATIENT'S INITIAL E2 RESULT WAS <18.35 PMOL/L ACCOMPANIED BY A DATA FLAG. THE DOCTOR QUESTIONED THE INITIAL RESULT WAS THERE WERE FOLLICLES PRESENT ON THE ULTRASOUND. THE SAMPLE WAS REPEATED AND THE E2 RESULTS WERE 5995 PMOL/L AND CONFIRMED AT 5786 PMOL/L. ON (B)(6) 2013, THE SAMPLE WAS REPEATED AGAIN AND THE E2 RESULT WAS 5840 PMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE E2 REAGENT LOT NUMBER WAS 168711 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172871 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR