BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 2212194 · Received August 15, 2011

    Report

    Report Number
    2919069-2011-00572
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT: NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4); DEVICE: LOW TEST RESULTS. (B)(4); AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS ISSUE MAY BE DUE TO A SAMPLE/TUBE-SPECIFIC PROBLEM OR AN INTERMITTENT INSTRUMENT PROBLEM THAT AFFECTED ONE TUBE. FIELD SERVICE REPLACED SOLENOID VALVES #11 AND 12, FOR SAMPLE PATH BACKFLUSH, AND ASPIRATION VACUUM, RESPECTIVELY, SUSPECTING AN INTERMITTENT PROBLEM. THE DECREASE IN RBC AND HGB COULD BE A SIGN OF THE SAMPLE SETTLING DOWN/NOT BEING MIXED WELL; HOWEVER, THERE WAS NOT MUCH OF A TIME DIFFERENCE BETWEEN RUNS, SO ALL THE RUNS IN THE CLOSED MODE SHOULD MIX REASONABLY WELL. IN ADDITION, THE REPEATED RUNS OF THE FIRST DRAW WERE CONSISTENT AND OTHER SAMPLES RUN BEFORE AND AFTER THE DISCREPANT RESULT DID NOT DISPLAY THE SAME ISSUE, WHICH MAKES THE SCENARIO OF AN INTERMITTENT PROBLEM UNLIKELY. IT IS INCONCLUSIVE AS TO WHY THE DISCREPANT HGB RESULTS WERE OBSERVED. THE COMPLAINT ALSO INDICATED THAT MULTIPLE ERROR MESSAGES (SIM 2077) WERE OBSERVED. PER THE INSTRUCTIONS IN SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS OF THE CELL-DYN RUBY SYSTEM OPERATOR'S MANUAL, REGARDING SIM 2077, IF THE SIM MESSAGE APPEARS REPEATEDLY, THE CUSTOMER IS TO CONTACT ABBOTT CUSTOMER SERVICE. CUSTOMER SERVICE WAS CONTACTED, BUT THE EVENT LOG SHOWS THAT THE SIM LAST OCCURRED IN MAY 2011 BEFORE THE ONE OBSERVED IN JULY 2011 (FOR THIS COMPLAINT). NO INDICATIONS OF REPEATED SIM 2077 WERE OBSERVED ON THE DATE THE COMPLAINT ISSUE WAS RECORDED. A REVIEW OF THE INSTRUMENT SERVICE HISTORY AND COMPLAINT RECORDS WAS PERFORMED AS PART OF THE EVALUATION. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN RUBY INSTRUMENT.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A DEPRESSED HEMOGLOBIN RESULT (5.71, 5.78 G/DL) ON A PATIENT SAMPLE THAT PREVIOUSLY GENERATED THE EXPECTED HEMOGLOBIN RESULT OF 8.85 G/ DL WHEN PROCESSING ON THE CELL-DYN RUBY. THE ACCOUNT STATED THE CELL-DYN RUBY GENERATED AN SIM 2077 ERROR WHICH REQUIRED THE POWER TO BE CYCLED. AFTER CYCLING POWER ON THE CELL-DYN RUBY, THE HEMOGLOBIN VALUES WERE DEPRESSED ON THIS PATIENT SAMPLE. A NEW SPECIMEN WAS OBTAINED WHICH GENERATED CELL-DYN RUBY HEMOGLOBIN OF 8.54 G/DL. NO PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. DATA PROVIDED: (B)(4). 1ST RUN, WBC: 10.0 (10E3/UL), RBC: 3.25 (10E6/UL), HGB: 8.85 (G/DL), PLT: 246 (10E3/UL), TIME: 14:50, 15:00, 15:09. SIM 2077 ERROR CYCLE POWER, BACKGROUND PERFORMED: 2ND RUN: 12.0, 2.09, 5.71, 297, 15:27; 3RD RUN: 12.2, 2.15, 5.78, 302, 16:34; REDRAW: 10.4, 3.09, 8.54, 250, 17:12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN RUBY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1