BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 2934303 · Received January 30, 2013

    Report

    Report Number
    1823260-2013-00523
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 13, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    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

    THE INVESTIGATION WAS NOT ABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THE DATA PROVIDED BY THE CUSTOMER WAS EVALUATED. THE CALIBRATION AND QC DATA DID NOT INDICATE AN ISSUE. THE ALARM TRACE FROM THE INSTRUMENT ALSO DID NOT SHOW AN ISSUE. AN ELECTROMAGNETICAL INFLUENCE WAS NOT INDICATED, BUT COULD NOT BE RULED OUT. IT WAS NOTED THAT THERE WAS AN INSUFFICIENT CENTRIFUGATION TIME OF 10 MINUTES INSTEAD OF 15 MINUTES IN COMBINATION WITH A G-FORCE SETTING THAT WAS TOO LOW.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON TROPONIN T SHORT TURN AROUND TIME (TNT STAT) FOR ONE PATIENT SAMPLE. ALL RESULTS ARE IN NG/ML. THE PATIENT HAD AN INITIAL RESULT OF 0.058, ACCOMPANIED BY A DATA FLAG AT 10:26. THE PREVIOUS TNT STAT RESULT FOR THIS PATIENT FROM 4:30 AM ON (B)(6) 2013 WAS NEGATIVE. THE CUSTOMER RE-RAN THE ORIGINAL SAMPLE TUBE ON AN ELECSYS 2010 SERIAL NUMBER (B)(4), AND GENERATED A RESULT OF <0.010, ACCOMPANIED BY A DATA FLAG AT 10:40. SINCE THE TNT STAT RESULTS DID NOT MATCH, THE CUSTOMER RAN AN ADDITIONAL SAMPLE TUBE THAT WAS DRAWN AT THE SAME TIME ON ELECSYS 2010 SERIAL NUMBER (B)(4), AND AT 10:54, GENERATED A RESULT OF <0.010, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AGAIN ON THIS ELECSYS AND AT 10:57, GENERATED RESULTS OF <0.010, ACCOMPANIED BY A DATA FLAG. THE CUSTOMER ALSO RAN FIVE ALIQUOTS OF THE ORIGINAL SAMPLE TUBE. THOSE RESULTS WERE ALL <0.010. THE CUSTOMER DID NOT REPORT THE INITIAL RESULT OF 0.058 OUTSIDE OF THE LABORATORY. THEY CONSIDERED THE REPEAT RESULTS, AND THE RESULTS FROM THE OTHER ANALYZER TO BE THE CORRECT RESULTS. THERE WAS NO ADVERSE EVENT. THE LOT OF TNT STAT REAGENT IN USE WAS 17016701, WITH AN EXPIRATION DATE OF 11/30/2013. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO FIND A CAUSE FOR THE EVENT. HE CHECKED THE INSTRUMENT AND DID PERFORMANCE TESTING AND QC; THE VALUES WERE WITHIN THE EXPECTED RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40615 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR