BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPA

    MDR report key: 1061923 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04733
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE PATIENT SAMPLES WITH DISCREPANT POTASSIUM OR ALT RESULTS. PATIENT 1, INITIAL POTASSIUM GAVE 4.8 MMOL/L; REPEAT GAVE 3.2 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE MIS-ADJUSTMENT OF THE CENTRIFUGE RACK FEED PROCESS. THIS MISADJUSTMENT SENT SAMPLES THAT HAD NOT BEEN PROPERLY SPUN TO THE CHEMISTRY ANALYZER FOR ANALYSIS. THE FIELD SERVICE REPRESENTATIVE RELUBRICATED RACKS AND PINS ON CENTRIFUGE BUCKETS ON MPA. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 2

    THREE PATIENT SAMPLES WITH DISCREPANT POTASSIUM OR ALT RESULTS. PATIENT 2, INITIAL POTASSIUM GAVE 5.6 MMOL/L; 4.5 MMOL/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE MIS-ADJUSTMENT OF THE CENTRIFUGE RACK FEED PROCESS. THIS MISADJUSTMENT SENT SAMPLES THAT HAD NOT BEEN PROPERLY SPUN TO THE CHEMISTRY ANALYZER FOR ANALYSIS. THE FIELD SERVICE REPRESENTATIVE RELUBRICATED RACKS AND PINS ON CENTRIFUGE BUCKETS ON MPA. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 3

    THREE PATIENT SAMPLES WITH DISCREPANT POTASSIUM OR ALT RESULTS. PATIENT 3, INITIAL ALT GAVE 187 U/L; REPEAT GAVE 13 U/L. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE MIS-ADJUSTMENT OF THE CENTRIFUGE RACK FEED PROCESS. THIS MISADJUSTMENT SENT SAMPLES THAT HAD NOT BEEN PROPERLY SPUN TO THE CHEMISTRY ANALYZER FOR ANALYSIS. THE FIELD SERVICE REPRESENTATIVE RELUBRICATED RACKS AND PINS ON CENTRIFUGE BUCKETS ON MPA. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPA AUTOMATED PREANALYTICAL SYSTEM JJE ROCHE DIAGNOSTICS MPA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK
    2 UNK
    3 UNK