BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1446383 · Received May 26, 2009

    Report

    Report Number
    1823260-2009-03675
    Event Type
    Malfunction
    Date Received
    May 26, 2009
    Date of Event
    April 29, 2009
    Report Date
    May 26, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCING PATIENT IMPRECISION ISSUES FOR VITAMIN B12. NO ACTUAL PATIENT RESULTS WERE PROVIDED, HOWEVER, THE CUSTOMER PROVIDED PATIENT DATA FOR 8 PATIENT SAMPLES OBTAINED FROM A PRECISION STUDY RUN TO TROUBLESHOOT THE ISSUE. THE FOLLOWING 3 PATIENT EXAMPLES WERE DETERMINED TO BE DISCREPANT. TEN ALIQUOTS WERE MADE FOR SAMPLES 1 & 2 AND MEASURED; SAMPLE 3 WAS ALIQUOTED 9 TIMES AND MEASURED. SAMPLE 1, GAVE 95, 67, 170, 99, 103, 84, 95, 87, 165 AND 85 PG PER ML. SAMPLE 2, GAVE 133, 135, 157, 127, 105, 196, 139, 126, 129, 129, & 153 PG PER ML. SAMPLE 3 WAS RUN AFTER THE FIELD SERVICE ENGINEER REPLACED THE MEASURING CELL, GIVING 115.8, 154.2, 154.1, 111.1, 115.2, 148.5, 188.4, 155.9 AND 126.3. IT WAS NOTED THAT BASED ON THE CUSTOMER DATA, A RESULT OF EITHER 67 OR 165 IS STILL WELL BELOW REFERENCE RANGE. NO INFORMATION PROVIDED TO DETERMINE IF ANY PATIENTS WERE ADVERSELY AFFECTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK