BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1311436 · Received February 6, 2009

    Report

    Report Number
    1823260-2009-00995
    Event Type
    Malfunction
    Date Received
    February 6, 2009
    Date of Event
    January 17, 2009
    Report Date
    February 6, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS AN ELECTRONIC FAILURE OF THE MEASURING CELL AND REPLACED IT. HE PERFORMED CALIBRATION AND QUALITY CONTROL. ALL CONTROLS WERE ACCEPTABLE TO USER.

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT RESULTS FOR MULTIPLE ASSAYS FOR A TOTAL OF SIX PATIENT SAMPLES. ALL REPEAT TESTING WAS PERFORMED ON ANOTHER ANALYZER AT THE SITE. SAMPLE 1 - ORIGINAL TROPONIN T RESULT WAS 0.034 NG/ML, REPEAT RESULT WAS 0.012 NG/ML. USER STATED THEY WERE NOT REPORTING ANY PATIENT RESULTS FROM THIS ANALYZER.

    Additional Manufacturer Narrative · 2

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS AN ELECTRONIC FAILURE OF THE MEASURING CELL AND REPLACED IT. HE PERFORMED CALIBRATION AND QUALITY CONTROL. ALL CONTROLS WERE ACCEPTABLE TO USER.

    Description of Event or Problem · 2

    USER RECEIVED DISCREPANT RESULTS FOR MULTIPLE ASSAYS FOR A TOTAL OF SIX PATIENT SAMPLES. ALL REPEAT TESTING WAS PERFORMED ON ANOTHER ANALYZER AT THE SITE. SAMPLE 2 - ORIGINAL TROPONIN T RESULT WAS 0.118 NG/ML, REPEAT RESULT WAS 0.078 NG/ML. ORIGINAL CKMB RESULT WAS 6.25 NG/ML, REPEAT RESULT WAS 4.06 NG/ML. USER STATED THEY WERE NOT REPORTING ANY PATIENT RESULTS FROM THIS ANALYZER.

    Additional Manufacturer Narrative · 3

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS AN ELECTRONIC FAILURE OF THE MEASURING CELL AND REPLACED IT. HE PERFORMED CALIBRATION AND QUALITY CONTROL. ALL CONTROLS WERE ACCEPTABLE TO USER.

    Description of Event or Problem · 3

    USER RECEIVED DISCREPANT RESULTS FOR MULTIPLE ASSAYS FOR A TOTAL OF SIX PATIENT SAMPLES. ALL REPEAT TESTING WAS PERFORMED ON ANOTHER ANALYZER AT THE SITE. SAMPLE 3 - ORIGINAL TROPONIN T RESULT WAS 0.079 NG/ML, REPEAT RESULT WAS 0.049 NG/ML. ORIGINAL CKMB RESULT WAS 6.31 NG/ML, REPEAT RESULT WAS 4.23 NG/ML. ORIGINAL MYOGLOBIN RESULT WAS 71.00 NG/ML, REPEAT RESULT WAS 40.36 NG/ML. USER STATED THEY WERE NOT REPORTING ANY PATIENT RESULTS FROM THIS ANALYZER.

    Additional Manufacturer Narrative · 4

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS AN ELECTRONIC FAILURE OF THE MEASURING CELL AND REPLACED IT. HE PERFORMED CALIBRATION AND QUALITY CONTROL. ALL CONTROLS WERE ACCEPTABLE TO USER.

    Description of Event or Problem · 4

    USER RECEIVED DISCREPANT RESULTS FOR MULTIPLE ASSAYS FOR A TOTAL OF SIX PATIENT SAMPLES. ALL REPEAT TESTING WAS PERFORMED ON ANOTHER ANALYZER AT THE SITE. SAMPLE 4 - ORIGINAL CKMB RESULT WAS 4.96 NG/ML, REPEAT RESULT WAS 3.02 NG/ML. USER STATED THEY WERE NOT REPORTING ANY PATIENT RESULTS FROM THIS ANALYZER.

    Additional Manufacturer Narrative · 5

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS AN ELECTRONIC FAILURE OF THE MEASURING CELL AND REPLACED IT. HE PERFORMED CALIBRATION AND QUALITY CONTROL. ALL CONTROLS WERE ACCEPTABLE TO USER.

    Description of Event or Problem · 5

    USER RECEIVED DISCREPANT RESULTS FOR MULTIPLE ASSAYS FOR A TOTAL OF SIX PATIENT SAMPLES. ALL REPEAT TESTING WAS PERFORMED ON ANOTHER ANALYZER AT THE SITE. SAMPLE 5 - ORIGINAL CKMB RESULT WAS 3.65 NG/ML, REPEAT RESULT WAS 1.81 NG/ML. ORIGINAL MYOGLOBIN RESULT WAS 55.00 NG/ML, REPEAT RESULT WAS LESS THAN 21.0 NG/ML. USER STATED THEY WERE NOT REPORTING ANY PATIENT RESULTS FROM THIS ANALYZER.

    Additional Manufacturer Narrative · 6

    THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS AN ELECTRONIC FAILURE OF THE MEASURING CELL AND REPLACED IT. HE PERFORMED CALIBRATION AND QUALITY CONTROL. ALL CONTROLS WERE ACCEPTABLE TO USER.

    Description of Event or Problem · 6

    USER RECEIVED DISCREPANT RESULTS FOR MULTIPLE ASSAYS FOR A TOTAL OF SIX PATIENT SAMPLES. ALL REPEAT TESTING WAS PERFORMED ON ANOTHER ANALYZER AT THE SITE. SAMPLE 6 - ORIGINAL CKMB RESULT WAS 5.39 NG/ML, REPEAT RESULT WAS 3.47 NG/ML. USER STATED THEY WERE NOT REPORTING ANY PATIENT RESULTS FROM THIS ANALYZER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2 UNK
    3 UNK
    4 UNK
    5 UNK
    6 UNK