BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 2895397 · Received January 3, 2013

    Report

    Report Number
    1823260-2013-00065
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 15, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. REAGENT INTEGRITY COULD NOT BE EVALUATED BASED ON LIMITED INFORMATION. INSTRUMENT ISSUES ARE ALSO POSSIBLE SINCE SEVERAL ITEMS WERE REPLACED IN THE COURSE OF THE FIELD SERVICE REPRESENTATIVE ACTIONS. NO ADVERSE EVENTS WERE REPORTED FOR ANY OF THE PATIENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TROPONIN T (TNT). THE SAMPLE INITIALLY RESULTED AS 0.116 NG/ML ON AN E170 ANALYZER. THE RESULT OF 0.116 NG/ML WAS REPORTED OUTSIDE OF THE LABORATORY AND BELIEVED TO BE THE CORRECT RESULT. THE SAMPLE WAS REPEATED PER LABORATORY PROTOCOL ON THE ELECSYS 2010 ANALYZER, RESULTING AS <0.010 NG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AGAIN ON BOTH INSTRUMENTS WITH RESULTS OF 0.126 NG/ML ON THE E170 ANALYZER, AND 0.128 NG/ML ON THE ELECSYS 2010 ANALYZER. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE TNT REAGENT LOT NUMBER WAS 16887801 WITH AN EXPIRATION DATE OF 08/31/2013. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE MONITORED VOLTAGES VIA THE VOLTAGE MONITOR. HE CHECKED MIXER SPEED. ALL VOLTAGES AND THE MIXER SPEED WERE WITHIN SPECIFICATIONS. HE PERFORMED VERTICAL AND HORIZONTAL PROBE ADJUSTMENTS ON BOTH THE S/R PROBE AND SIPPER PROBE. HE REPLACED THE WATER RESERVOIR VALVE BODY. HE REPLACED THE TUBING FROM THE ACRYLIC BLOCK TO THE S/R PROBE. HE REPLACED THE PINCH TUBING AND CLEANED THE INLET WATER FILTER. HE REPLACED THE ON BOARD TNT REAGENT PACK. HE RAN PERFORMANCE TESTING AND AN INITIAL BLANK CELL CALIBRATION. HE RAN TNT CALIBRATION AND QUALITY CONTROLS. ALL TESTS AND CHECKS WERE WITHIN ROCHE DOCUMENTED GUIDELINES. ALL OF THE CUSTOMER'S CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN THEIR SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1