BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1542756 · Received November 17, 2009

    Report

    Report Number
    1823260-2009-07870
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    October 25, 2009
    Report Date
    November 17, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED A SHIFT IN THE CKMB QC RECOVERY ON THE E601 WHEN CHANGING TO A NEW LOT NUMBER OF REAGENT. THE USER PERFORMED A PATIENT COMPARISON AND RECEIVED DISCREPANT RESULTS FOR FIVE SAMPLES. THE INITIAL RESULTS WERE TESTED ON (B)(6) 2009, WITH REAGENT LOT NUMBER 153686 AND THE RESULTS WERE REPORTED. THE SAMPLES WERE RERUN ON (B)(6) 2009, FOR TROUBLESHOOTING THE QC SHIFT WITH REAGENT LOT NUMBER 155150. THE SAMPLES WERE ALL IN 5 ML LITHIUM HEPARIN TUBES. ALL RESULTS ARE IN NG PER ML. SAMPLE 1, INITIAL RESULT WAS 2.75, REPEAT RESULT WAS 1.73. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE REAGENT LOT CHANGE. HE INSPECTED THE ANALYZER AND PERFORMED MECHANISM CHECKS WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 2

    THE USER REPORTED A SHIFT IN THE CKMB QC RECOVERY ON THE E601 WHEN CHANGING TO A NEW LOT NUMBER OF REAGENT. THE USER PERFORMED A PATIENT COMPARISON AND RECEIVED DISCREPANT RESULTS FOR FIVE SAMPLES. THE INITIAL RESULTS WERE TESTED ON (B)(6) 2009 WITH REAGENT LOT NUMBER 153686 AND THE RESULTS WERE REPORTED. THE SAMPLES WERE RERUN ON (B)(6) 2009 FOR TROUBLESHOOTING THE QC SHIFT WITH REAGENT LOT NUMBER 155150. THE SAMPLES WERE ALL IN 5 ML LITHIUM HEPARIN TUBES. ALL RESULTS ARE IN NG PER ML. SAMPLE 2, INITIAL RESULT WAS 4.81, REPEAT RESULT WAS 3.77. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE REAGENT LOT CHANGE. HE INSPECTED THE ANALYZER AND PERFORMED MECHANISM CHECKS WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 3

    THE USER REPORTED A SHIFT IN THE CKMB QC RECOVERY ON THE E601 WHEN CHANGING TO A NEW LOT NUMBER OF REAGENT. THE USER PERFORMED A PATIENT COMPARISON AND RECEIVED DISCREPANT RESULTS FOR FIVE SAMPLES. THE INITIAL RESULTS WERE TESTED ON (B)(6) 2009 WITH REAGENT LOT NUMBER 153686 AND THE RESULTS WERE REPORTED. THE SAMPLES WERE RERUN ON (B)(6) 2009 FOR TROUBLESHOOTING THE QC SHIFT WITH REAGENT LOT NUMBER 155150. THE SAMPLES WERE ALL IN 5 ML LITHIUM HEPARIN TUBES. ALL RESULTS ARE IN NG PER ML. SAMPLE 3, INITIAL RESULT WAS 9.34, REPEAT RESULT WAS 7.7.. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE REAGENT LOT CHANGE. HE INSPECTED THE ANALYZER AND PERFORMED MECHANISM CHECKS WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 4

    THE USER REPORTED A SHIFT IN THE CKMB QC RECOVERY ON THE E601 WHEN CHANGING TO A NEW LOT NUMBER OF REAGENT. THE USER PERFORMED A PATIENT COMPARISON AND RECEIVED DISCREPANT RESULTS FOR FIVE SAMPLES. THE INITIAL RESULTS WERE TESTED ON (B)(6) 2009 WITH REAGENT LOT NUMBER 153686 AND THE RESULTS WERE REPORTED. THE SAMPLES WERE RERUN ON (B)(6) 2009 FOR TROUBLESHOOTING THE QC SHIFT WITH REAGENT LOT NUMBER 155150. THE SAMPLES WERE ALL IN 5 ML LITHIUM HEPARIN TUBES. ALL RESULTS ARE IN NG PER ML. SAMPLE 4, INITIAL RESULT WAS 4.25, REPEAT RESULT WAS 3.24. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE REAGENT LOT CHANGE. HE INSPECTED THE ANALYZER AND PERFORMED MECHANISM CHECKS WITH ACCEPTABLE RESULTS.

    Description of Event or Problem · 5

    THE USER REPORTED A SHIFT IN THE CKMB QC RECOVERY ON THE E601 WHEN CHANGING TO A NEW LOT NUMBER OF REAGENT. THE USER PERFORMED A PATIENT COMPARISON AND RECEIVED DISCREPANT RESULTS FOR FIVE SAMPLES. THE INITIAL RESULTS WERE TESTED ON (B)(6) 2009 WITH REAGENT LOT NUMBER 153686 AND THE RESULTS WERE REPORTED. THE SAMPLES WERE RERUN ON (B)(6) 2009 FOR TROUBLESHOOTING THE QC SHIFT WITH REAGENT LOT NUMBER 155150. THE SAMPLES WERE ALL IN 5 ML LITHIUM HEPARIN TUBES. ALL RESULTS ARE IN NG PER ML. SAMPLE 5, INITIAL RESULT WAS 2.75, REPEAT RESULT WAS 1.82. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE REAGENT LOT CHANGE. HE INSPECTED THE ANALYZER AND PERFORMED MECHANISM CHECKS WITH ACCEPTABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR
    2 47 YR
    3 70 YR
    4 43 YR
    5 UNK