BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1057334 · Received June 6, 2008

    Report

    Report Number
    1823260-2008-04531
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE REP UNABLE TO DETERMINE ROOT CAUSE, BUT VERIFIED PROBE ALIGNMENTS AND CHECKED ELECTRODES. PERFORMANCE TESTS WERE PERFORMED AND WERE WITHIN SPECS.

    Description of Event or Problem · 1

    APPROX 30 PATIENTS WITH DISCREPANT SODIUM (NA) AND POTASSIUM (K) RESULTS. INITIAL RESULTS REPORTED. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. RESULTS REPEATED ON ORIGINAL ANALYZER AND DIFFERENT ANALYZER (SAME METHODOLOGY). ALL RESULTS IN MMOL/LL. PATIENT (PT) 1 INITIAL NA 134, REPEATED 140, 139, 148, 150. PT 2 INITIAL NA 133, REPEATED 136, 136, 139, 142. PT 3 INITIAL NA 131, REPEATED 133, 132, 136, 138. PT 4 INITIAL NA 134, REPEATED 134, 133, 138, 141. PT 5 INITIAL NA 134, REPEATED 142, 141, 152, 155. INITIAL K 3.50, REPEATED 3.74, 3.72, 4.02, 4.08. PT 6 INITIAL NA 133, REPEATED 138, 137, 144, 148. INITIAL K 5.50, REPEATED 5.58, 5.75, 6.07, 6.21. PT 7 INITIAL NA 129, REPEATED 131, 136, 151, 156. INITIAL K 4.50, REPEATED 4.73, 4.67, 5.25, 5.42. PT 8 INITIAL NA 126, REPEATED 131, 129, 136, 139. PT 9 INITIAL K 5.40, REPEATED 5.7, 5.59, 6.28. PT 10 INITIAL NA 134, REPEATED 137, 136, 142, 146. PT 11 INITIAL NA 130, REPEATED 131, 132, 133, 136. PT 12 INITIAL NA 132, REPEATED 136, 136, 143, 149. PT 13 INITIAL K 4.50, REPEATED 4.86, 4074 AND 5.4. PT 14 INITIAL NA 132, REPEATED 136, 135, 137, 139. PT 15 INITIAL NA 133, REPEATED 137, 136, 138, 139. PT 16 INITIAL NA 133, REPEATED 139, 139, 139, 141. PT 17 INITIAL NA 130, REPEATED 138, 136, 145, 148. INITIAL K 5.4 REPEATED 5.62, 5.54, 5.98, 6.11. PT 18 INITIAL NA 132, REPEATED 137, 138, 139, 141. PT 19 INITIAL NA 132, REPEATED 135, 134, 141, 143. PT 20 INITIAL NA 133, REPEATED 139,140, 141, 142. PT 21 INITIAL NA 134, REPEATED 142,140, 153, 156. INITIAL K 4.3 REPEATED 4.48, 4.46, 4.83, 4.95. PT 22 INITIAL NA 134, REPEATED 140, 140 142, 143. PT 23 INITIAL NA 132, REPEATED 140, 139, 144, 146. PT 24 INITIAL NA 131, REPEATED 137, 137, 141, 144. PT 25 INITIAL NA 130, REPEATED 135, 136, 139, 142. PT 26 INITIAL NA 134, REPEATED 140, 140, 153, 156. INITIAL K 5.4, REPEATED 5.65, 5.63, 6.12, 6.28. PT 27 INITIAL NA 132, REPEATED 136, 137, 139. PT 28 INITIAL NA 133, REPEATED 135, 134, 138, 140. PT 29 INITIAL NA 131, REPEATED 133, 133, 140, 144. PT 30 INITIAL NA 133, REPEATED 133, 133, 139, 142.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER-CEM JJE ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK