BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 2896599 · Received January 4, 2013

    Report

    Report Number
    1823260-2013-00080
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 15, 2012
    Report Date
    January 4, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE SUBASSEMBLY- PINCH TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR TROPONIN T SHORT TURN AROUND TIME (TNT STAT) ON ONE PATIENT SAMPLE. ALL RESULTS ARE IN NG/ML. THE ORIGINAL RESULT WAS 0.049, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS THEN REPEATED ON THE SAME ANALYZER. THE REPEAT RESULT WAS 0.121, ACCOMPANIED BY A DATA FLAG. NEITHER OF THESE RESULTS WERE DEEMED BY THE CUSTOMER TO BE CORRECT. THESE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS THEN RUN TWICE ON ANOTHER ELECSYS 2010 ANALYZER, SERIAL NUMBER (B)(4). THE FIRST REPEAT RESULT WAS 0.059, ACCOMPANIED BY A DATA FLAG. THE SECOND REPEAT RESULT WAS 0.058, ACCOMPANIED BY A DATA FLAG. THESE RESULTS WERE THOUGHT TO BE CORRECT AND WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE LOT OF TNT STAT REAGENT IN USE WAS 16887901; WITH AN EXPIRATION DATE OF 08/31/2013. THE FIELD SERVICE REPRESENTATIVE SUSPECTED AN ISSUE WITH THE PINCH TUBING. HE REPLACED THE PINCH TUBING, REBUILT SYRINGES AND CLEANED THE ANALYZER. HE ALSO ADJUSTED THE HIGH VOLTAGE AND DELETED THE CUSTOMER CALIBRATION. HE EXECUTED PERFORMANCE TESTING AND PRECISION TESTING WHICH WAS WITHIN ACCEPTABLE RANGES. THE CUSTOMER RE-CALIBRATED AND RAN ALL QC, WHICH WAS WITHIN ACCEPTABLE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5507 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1