BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 2871653 · Received December 13, 2012

    Report

    Report Number
    1823260-2012-06316
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 1, 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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE CALIBRATION AND QUALITY CONTROL DATA DID NOT INDICATE AN ISSUE. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED RACK ADAPTORS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE TROPONIN T STAT (TNT) RESULT ON THEIR ELECSYS 2010 ANALYZER. THE PATIENT'S INITIAL TNT RESULT WAS <0.010 NG/ML ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED OUTSIDE THE LABORATORY. LATER THAT DAY, THE PATIENT HAD ANOTHER SAMPLE DRAWN AND THE RESULT WAS 0.174 NG/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR CALLED TO QUESTION THE RESULT OF <0.010 NG/ML. THE CAPPED SAMPLE WAS TAKEN FROM THE REFRIGERATOR AND REPEATED ON THE SAME ANALYZER AS THE INITIAL RESULT. THE REPEAT RESULT WAS 0.144 NG/ML ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS CONSIDERED CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TNT REAGENT LOT NUMBER WAS 16887901 AND THE EXPIRATION DATE WAS 08/31/2013. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE THE CAUSE OF THIS EVENT. HE CHECKED THE PROPER VOLTAGES OF THE S/R PROBE, THE SIPPER PROBE, AND THE PRESSURE SENSOR. HE CHECKED THE REAGENT BEAD MIXER FOR STRAIGHTNESS AND MIXING SPEED OF 2050 RPM. HE CHECKED THE S/R AND SIPPER ABNORMAL DESCENT SENSOR AND ALL PROBE ADJUSTMENTS. HE CHECKED THE RACK TRANSPORT FOR PROPER SAMPLING POSITION. HE CHECKED THE PINCH VALVE OPERATION AND PINCH VALVE TUBING INTEGRITY. HE CHECKED THE BLACK SIPPER TUBING AND S/R TUBING FOR ANY POSSIBLE LEAKS, BUT FOUND NONE. HE VERIFIED THE PROPER SYSTEM VOLUME CHECK. HE VERIFIED THE ENVIRONMENTAL OPERATING CONDITIONS OF THE LABORATORY WERE WITHIN SPECIFICATION. HE RAN SUCCESSFULLY PERFORMANCE CHECKS. ALL INSTRUMENT AND ASSAY PERFORMANCE CHECKS PASSED WITHIN SPECIFICATION. THE CUSTOMER RAN QUALITY CONTROL WITH PASSING RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1