BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1803025 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04878
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 9, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A CLEAR CAUSE. A INSTRUMENT RELATED ISSUE SUCH AS A MIXER OR PROBE ISSUE AND/OR A PRE-ANALYTIC ISSUE SUCH AS IMPROPER SAMPLE MIXING MIGHT BE POSSIBLE REASONS FOR THE ERRONEOUS RESULTS. THE PATIENTS WERE NOT ADVERSELY AFFECTED NOR TREATED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TROPONIN T RESULTS FOR TWO PATIENT SAMPLES. PATIENT SAMPLE 1 ORIGINAL RESULT WAS 0.075 NG/L WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE, SO THE UNIT CALLED THE LABORATORY TO HAVE THE SAMPLE RETESTED AND SENT A SECOND SAMPLE FROM THE SAME PATIENT TO BE TESTED. THE REPEAT TROPONIN T RESULT FROM THE ORIGINAL SAMPLE WAS < 0.010 NG/L. THE REPEAT RESULT FROM THE ORIGINAL SAMPLE ON ELECSYS 2010 (B)(4) WAS < 0.010 NG/L. THE RESULT FROM THE SECOND SAMPLE DRAWN FROM THE PATIENT WAS < 0.010 NG/L. THE PATIENT WAS NOT ADVERSELY AFFECTED NOR TREATED DUE TO THE ORIGINAL TROPONIN T RESULT. PATIENT SAMPLE 2 ORIGINAL RESULT WAS 0.09 NG/ML AND REPEAT RESULTS WERE 0.054 AND 0.058 NG/ML. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE DISCREPANCY FOR PATIENT SAMPLE 2. THE TROPONIN T REAGENT LOT NUMBER WAS 15721901. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE STATED HE SUSPECTED A POOR QUALITY SAMPLE RUN PREVIOUSLY COULD HAVE STAINED THE MEASURING CELL AND CREATED THE FALSE RESULT. HE INSTALLED MEASURING CELL TUBINGS AND VERIFIED THE MECHANICAL ALIGNMENT FOR THE SAMPLE PROBE, MIXER AND SIPPER PROBE. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTS AND QUALITY CONTROL WITH RESULTS WITHIN ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 HOT BIOPSY FORCEPS WAS USED DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HOT BIOPSY FORCEPS FAILED TO PROVIDE ENERGY AND THEY WERE UNABLE TO CUT THE POLYP COMPLETELY. MINIMAL BLEEDING OCCURED AND CLIPS WERE USED TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1