BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1834185 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05442
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 26, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT DEMOGRAPHIC INFORMATION WAS RECEIVED AND DOCUMENTED IN THE MEDWATCH.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED WITH THE DATA PROVIDED FOR INVESTIGATION.THE PREANALYTICS FOR THE SAMPLE WERE ACCEPTABLE, THE QUALITY CONTROLS PRIOR TO THE EVENT WERE WITHIN RANGE. IN ADDITION, THE ALARM TRACE DID NOT SHOW ANY ISSUES. ANALYZER PERFORMANCE TESTING WAS WITHIN SPECIFICATION. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT C8000 ANALYZER HAS GENERATED DISCREPANT SODIUM (NA) AND CHLORIDE (CL) RESULTS ON A FOURTH PATIENT SAMPLE WHO HAS BEEN DIAGNOSED WITH A BLADDER TUMOR AND MELANOMA. THE INITIAL NA RESULT WAS 128 AND THE RETEST RESULT WAS 136. THE INITIAL CL RESULT WAS 111 AND THE RETEST RESULT WAS 102. THE UNITS OF MEASUREMENTS ARE MMOL/L. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 1

    IMPEDANCE MEASUREMENTS GREATER THEN 4000 OHMS ON SOME OF THE BIPOLAR PAIRS OCCURRED. AN IMPEDANCE MEASURE OF LESS THEN 250 OHMS WAS NOTED ALSO. THE POSSIBILITY OF AN OPEN CIRCUIT WAS DISCUSSED. THE PT'S STATUS/OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE TROPONIN T RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS E411 ANALYZER. THE INITIAL RESULT WAS 0.163 NG/ML WITH A DATA FLAG AND WAS REPORTED TO THE PHYSICIAN. A SECOND SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS <0.01 NG/ML. THE FIRST SAMPLE WAS REPEATED TWICE ON (B)(6) 2010 AND THE RESULT WAS <0.01 NG/ML WITH DATA FLAGS. AN ANGIOGRAM HAD BEEN ORDERED FOR THE PATIENT DUE TO THE ERRONEOUS INITIAL RESULT, BUT WAS CANCELLED WHEN THE RESULT FOR THE SECOND SAMPLE AND REPEAT RESULTS FOR THE FIRST SAMPLE WERE RECEIVED. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE DISCREPANCY. THE TROPONIN T REAGENT LOT NUMBER WAS 157219.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR