BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1080663 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05678
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS AN ISSUE WITH DISCREPANT PTH RESULTS. THIRTY-TWO EXAMPLES PROVIDED. INITIAL RESULTS OBTAINED IN 2008. ALL RESULTS IN PMOL/L. SAMPLE 1 INITIAL RESULT 13.1, REPEAT TWO DAYS LATER, 18.99; SAMPLE 2 INITIAL RESULT 4.3, REPEAT SAME DAY. 6.1; SAMPLE 3 INITIAL RESULT 49.7, REPEAT SAME DAY, 64.82; SAMPLE 4 INITIAL RESULT 2.9, REPEAT SAME DAY 4.07. SAMPLE 5 INITIAL RESULT 2.8, REPEAT SAME DAY, 4.94. SAMPLE 6 INITIAL RESULT <0.6, REPEAT A DAY AFTER ORIGINAL DATE, 2.11 AND REPEAT TWO DAYS AFTER THE ORIGINAL DATE, 2.21. SAMPLE 7 INITIAL RESULT 21.2, REPEAT SAME DAY, 49.97; SAMPLE 8 INITIAL RESULT 3.2, REPEAT SAME DAY, 8.78. SAMPLE 9 INITIAL RESULT 50.4, REPEAT THE DAY AFTER THE ORIGINAL DATE, 94.38 AND REPEAT THE NEXT DAY, 94.12. SAMPLE 10 INITIAL RESULT 11.1, REPEAT TWO DAYS AFTER ORIGINAL DATE, 26.27. SAMPLE 11 INITIAL RESULT 2.7, REPEAT SAME DAY, 8.57. SAMPLE 12 INITIAL RESULT 0.8, REPEAT A DAY AFTER ORIGINAL DATE, 3.29 AND REPEAT THE NEXT DAY, 3.16. SAMPLE 13 INITIAL RESULT 13.2, REPEAT SAME DAY, 31.44. SAMPLE 14 INITIAL RESULT 0.6, REPEAT ON THE DAY AFTER THE ORGINAL DATE, 3.63 AND REPEAT THE NEXT DAY, 3.61. SAMPLE 15 INITIAL RESULT <0.6, REPEAT ON SAME MONTH, 4.04 AND REPEAT THE DAY AFTER THE ORIGINAL DATE, 4.01. SAMPLE 16 INITIAL RESULT 3.4, REPEAT THE NEXT DAY, 12.02. SAMPLE 17 INITIAL RESULT 3.6, REPEAT SAME DAY, 11.35. SAMPLE 18 INITIAL RESULT 9.5, REPEAT ON THE SAME DAY, 21.26. SAMPLE 19 INITIAL RESULT <0.6, REPEAT A DAY AFTER THE ORIGINAL DATE, 10.8 AND REPEAT THE NEXT DAY, 10.79. SAMPLE 20 INITIAL RESULT <0.6, REPEAT A DAY AFTER THE ORIGINAL DATE, 3.0 AND REPEAT ON THE NEXT DAY, 3.07. SAMPLE 21 INITIAL RESULT <0.6, REPEAT THE DAY AFTER THE ORIGINAL DATE, 5.67 AND REPEAT THE NEXT DAY, 5.69. SAMPLE 22 INITIAL RESULT 3.4, REPEAT SAME DAY, 9.88. SAMPLE 23 INITIAL RESULT 4.1, REPEAT SAME DAY, 10.72. SAMPLE 24 INITIAL RESULT 6.2, REPEAT ON THE SAME DATE, 15.15. SAMPLE 25 INITIAL RESULT <0.6, REPEAT ON THE DAY AFTER THE ORIGINAL DATE, 3.58 AND REPEAT THE NEXT DAY, 3.55. SAMPLE 26 INITIAL RESULT <0.6, REPEAT ON THE DAY AFTER THE ORIGINAL DATE, 1.89 AND REPEAT 1.91. SAMPLE 27 INITIAL RESULT 2.4, REPEAT THE NEXT DAY, 7.41. SAMPLE 28 INITIAL RESULT 2.5, REPEAT SAME DAY, 10.24. SAMPLE 29 INITIAL RESULT 2.5, REPEAT SAME DAY, 8.94. SAMPLE 30 INITIAL RESULT 5.5, REPEAT ON THE SAME DAY, 15.07; SAMPLE 31; INITIAL RESULT 2.4, REPEAT SAME DAY, 8.58. SAMPLE 32 INITIAL RESULT 4.5, REPEAT ON THE DAY AFTER THE ORIGINAL DATE, 11.94 AND REPEAT THE NEXT DAY, 11.8. NO ERRONEOUS RESULTS WERE REPORTED. IF ADD'L INFO IS REC'D 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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK