BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT COMMANDER PPC

    MDR report key: 1341311 · Received March 12, 2009

    Report

    Report Number
    1628664-2009-00107
    Event Type
    Malfunction
    Date Received
    March 12, 2009
    Report Date
    February 13, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    K897158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WATER CANISTER, WATER/WASTE TUBING, VALVE MOUNT ASSEMBLY, MAIN DRIVE. THE CUSTOMER STATED THEY PERFORM DAILY, WEEKLY AND MONTHLY REQUIRED MAINTENANCE ON THE PPC, AND MENTIONED IT HAD BEEN A WHILE SINCE THEY HAD SERVICE FOR THE PPC. SERVICE WAS REQUESTED FOR POSSIBLE PPC INSTRUMENT CONTAMINATION. ABBOTT SERVICE (FSR) NOTICED THE PPC WATER SPRAYED ON THE TRAY NEAR THE END OF THE TRAY DURING A MANUAL WASH. THE FSR REALIGNED THE WASH ACTUATOR, REPLACED THE MAIN DRIVE, AND PERFORMED ALIGNMENTS TO RESOLVE THIS ISSUE. THE FSR THEN PERFORMED MAINTENANCE TO DECONTAMINATE THE SYSTEM, DUE TO A BROWN RESIDUE FOUND IN THE WATER TANK OF THE PPC. THE FSR REPLACED THE WATER TANK, EXTERNAL TUBING, AND THE WASH MANIFOLD ASSEMBLY. THE FSR REPLACED THE VALVE MOUNT ASSEMBLY, AND MAIN DRIVE F/S. THE FSR DETERMINED THE SYSTEM WAS PERFORMING PER LABELING AFTER SERVICE WAS COMPLETED. THE CUSTOMER STATED ALL HTLV TESTING RESULTS APPEARED TO BE FINE, AND THEY WERE NOT SEEING THE HIGH LEVEL OF INDETERMININT RESULTS THEY WERE SEEING BEFORE, AFTER THE FSR SERVICED THE PPC. THE CUSTOMER TECHNICAL ADVOCATE (CTA) ADVISED THE CUSTOMER ON THE IMPORTANCE OF FOLLOWING MAINTENANCE SCHEDULES TO PREVENT CONTAMINATION OF THE WATER CANISTER AND TUBING. THE COMMANDER PPC OPERATION MANUAL LISTS MAINTENANCE AND SERVICE PROCEDURES FOR THE PPC, AND CONTAINS CORRECTIVE ACTIONS FOR DISPENSE ACTUATOR ALIGNMENT ISSUES. THESE MAINTENANCE PROCEDURES INCLUDE THE PERFORMANCE OF DAILY, WEEKLY AND MONTHLY MAINTENANCE, QUARTERLY WATER CANISTER CLEANING, ANNUAL WASH MANIFOLD REPLACEMENT, AND REPLACEMENT OF THE WASH MANIFOLD GASKETS ANNUALLY OR AFTER 125,000 WASH CYCLES. THE HTLV PACKAGE INSERT WAS FOUND TO CONTAIN ADEQUATE INFORMATION ON INTENDED USE, HANDLING PRECAUTIONS, TEST PROCEDURE, INTERPRETATION OF RESULTS, AND LIMITATIONS OF THE PROCEDURE. THE PACKAGE INSERT NOTES UNDER INTENDED USE THE ABBOTT HTLV QUALITATIVE ASSAY IS A INTENDED TO BE USED AS A SCREEN FOR DONATED BLOOD AND AS AN AID IN THE CLINICAL DIAGNOSIS OF HTLV-I AND HTLV II INFECTION. THE INSERT NOTES UNDER HANDLING PRECAUTIONS TO AVOID MICROBIAL CONTAMINATION OF SPECIMENS, REAGENT, AND WATER USED FOR WASHING. UNDER TEST PROCEDURE THE INSERT NOTES TWO NEGATIVE CONTROLS, TWO HTLV-I POSITIVE CONTROLS, AND TWO HTLV-II POSITIVE CONTROLS SHOULD BE RUN WITH EACH RUN OF SPECIMENS. CONTROLS SHOULD BE DISPENSED AND DILUTED IN THE SAME MANNER AS SPECIMENS. THE MOST PROBABLE CAUSE OF THE DISCREPANT HTLV PATIENT RESULTS WAS THE CONTAMINATION OF THE PPC. THE CONTAMINATION WAS CAUSED BY A LACK OF MAINTENANCE/CLEANING. THE MISALIGNED WASH ACTUATOR MAY ALSO HAVE CONTRIBUTED TO THIS ISSUE. THE ACTUAL CAUSE OF THE SUSPECT HTLV PATIENT RESULTS COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THE INVESTIGATION OF THE ISSUE CONSISTED OF A REVIEW OF CUSTOMER COMPLAINTS, CURRENT COMMANDER PPC LABELING, AND THE INFORMATION PROVIDED INCLUDING THE COMPLAINT TEXT. THE COMMANDER PPC OPERATION MANUAL PROVIDES MAINTENANCE AND SERVICE PROCEDURES TO ENSURE THE PERFORMANCE OF THE PPC. FAILURE TO FOLLOW THESE PROCEDURES COULD RESULT IN CONTAMINATION OF THE PPC AND THE GENERATION OF ERRONEOUS RESULTS. THE COMPLAINT INFORMATION NOTES THE PPC WAS SERVICED AND DECONTAMINATED TO RESOLVE THIS HTLV RESULT ISSUE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT NOTICED INCREASED HTLV-I/II EIA REACTIVITY WHEN PROCESSING ON THE COMMANDER PPC ANALYZER. THE ACCOUNT STATED THAT 2 SPECIMENS THAT WERE HTLV-I/II EIA REPEATEDLY REACTIVE TESTED WESTERN BLOT NEGATIVE. NO SPECIFIC TESTING DATA WAS AVAILABLE. SERVICE WAS REQUESTED FOR THE COMMANDER PPC ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER PPC STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JQW ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 HTLV-I/II EIA LIST 7A92