BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010

    MDR report key: 2960351 · Received February 14, 2013

    Report

    Report Number
    1823260-2013-00867
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 27, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATION, HOWEVER ON THE BORDER OF A 3 STANDARD DEVIATION RANGE ON THE DAY OF THE EVENT. CALIBRATION DATA AND INSTRUMENT DATA WERE NOT AVAILABLE FOR FURTHER INVESTIGATION. PATIENT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE THYROTROPIN (TSH) RESULT ON THEIR 2010 ANALYZER FOR ONE PATIENT. THE PATIENT'S INITIAL TSH RESULT WAS 0.217 UIU/ML. THE CUSTOMER WAS NOT SURE ABOUT THE RESULT AS IT WAS NOTED THE QUALITY CONTROL RESULTS WERE LOW. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS SEND TO ANOTHER LABORATORY FOR TESTING. THE REPEAT RESULT WAS 0.006 UIU/ML. THE CUSTOMER CONSIDERED THIS RESULT TO BE CORRECT AND IT WAS APPROVED AND REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RECEIVED THE PATIENT SAMPLE BACK TO RETEST AND THE CUSTOMER STATED THE RESULT WAS STILL "0.2XX UIU/ML". THERE WERE NO ADVERSE EVENTS. THE TSH REAGENT LOT NUMBER WAS 169972 AND THE EXPIRATION DATE WAS 05/30/2013. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE TO PERFORM MAINTENANCE ON THE ANALYZER. THE CUSTOMER PUT A NEW TSH REAGENT PACK ON THE ANALYZER. QUALITY CONTROL WAS PERFORMED ALONG WITH PATIENT SAMPLES AND THE RESULTS SEEMED OK. AFTER THE PROBLEM WAS SOLVED, THE CUSTOMER SENT FIVE SAMPLES TO ANOTHER LABORATORY FOR REPEAT TESTING, AND THE REPEAT RESULTS MATCHED THE CUSTOMER'S RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64797 ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1