BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 2948113 · Received November 15, 2006

    Report

    Report Number
    1628664-2006-00089
    Event Type
    Other
    Date Received
    November 15, 2006
    Date of Event
    October 26, 2006
    Report Date
    October 26, 2006
    Manufacturer
    ABBOTT MFG INC
    Product Code
    CGZ
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED CUVETTES OVERFILLING AT HIGH CONCENTRATION (HC) NOZZLE B, AND ALSO NOTED 1 OF 20 CUVETTES BEING FULL OF FLUID WHEN IT REACHES THE SAMPLE PROBE. THE CUSTOMER ALSO EXPERIENCED ABSORBANCE READ FLUCTUATION. ABBOTT CUSTOMER SERVICE AND SUPPORT (CSS) RECOMMENDED CHANGING THE WATER BATH TO ADDRESS THE ABS READ FLUCTUATION WARNING. CSS ALSO INSTRUCTED THE CUSTOMER TO REPLACE THE BELLOWS AND DISCOVERED THE FRONT POPPET WAS INSTALLED BACKWARDS. AFTER PROPER INSTALLATION FLUID WAS STILL NOT ASPIRATING THROUGH HC NOZZLE B. CSS RECOMMENDED STYLETTING THE NOZZLE, BUT NO OBSTRUCTION WAS FOUND. ABBOTT FIELD SERVICE (FS) REPLACED MULTIPLE PARTS THAT WERE WORN, CLOGGED, CRIMPED OR MISALIGNED INCLUDING THE ICT MODULE, REAGENT PROBES R1B, R2A, AND 1B, CUVETTE WASHER NOZZLE PAIR #7, TWO SYRINGE O-RINGS, SAMPLE SYRINGE SEAL TIPS #1 AND #2, TWO CUVETTE DRYING TIPS, CUVETTE WASHER NOZZLE PAIRS 1, 4, 5, WASTE, DI, A BELLOWS SET, ROD AND JOINT, POPPET VALVE, AND HIGH CONCENTRATION WASTE PUMP A AND B. TROUBLESHOOTING AND DIAGNOSTICS OF THE AEROSET OPERATIONS MANUAL INCLUDES SUFFICIENT LABELING WITH REGARD TO TROUBLESHOOTING ERROR LOG MESSAGE 350 ABSORBANCE READ FLUCTUATION WARNING AND THE CUSTOMER'S OBSERVED PROBLEM OF RESULTS ARE ERRATIC, PRECISION IS POOR, WHICH COULD ALSO PRESENT ITSELF AS CONTROLS ARE OUT OF RANGE. PROBABLE CAUSES LISTED FOR ERROR LOG MESSAGE 350 INCLUDE BUT ARE NOT LIMITED TO: DEBRIS IN WATER BATH, REAGENT PROBES ARE NOT DISPENSING CORRECTLY, DISPENSE SYSTEM IS NOT PERFORMING AS EXPECTED. PROBABLE CAUSES LISTED FOR ERRATIC RESULTS AND CONTROLS OUT OF RANGE INCLUDE, BUT ARE NOT LIMITED TO: SCHEDULED MAINTENANCE IS DUE, CUVETTE WASHER IS MALFUNCTIONING, TUBING IS CRIMPED, AND SAMPLE OR REAGENT PROBE IS PARTIALLY OBSTRUCTED. THE MANUAL INSTRUCTS THE USER TO CONTACT ABBOTT CUSTOMER SUPPORT FOR UNRESOLVED PROBLEMS. SECTION 9 SERVICE AND MAINTENANCE PROVIDES MAINTENANCE INSTRUCTIONS TO THE USER: DAILY - PERFORM STARTUP (WHICH INCLUDES THE OPTION TO CHANGE THE WATER BATH), CHECK SYRINGES; WEEKLY - CHECK SAMPLE AND REAGENT PROBES, CHECK ICT PROBE AND TUBING; MONTHLY - CHECK SAMPLE AND REAGENT DISPENSE COMPONENTS, CLEAN CUVETTE WASHER NOZZLES, CHECK CUVETTE WASHER HIGH-CONCENTRATION WASTE NOZZLE TUBING; AND QUARTERLY - SYRINGE SEAL TIP (1 AND 2) AND O-RING REPLACEMENT. THE ANALYZER COMPONENT REPLACEMENT SECTION PROVIDES INSTRUCTIONS FOR REPLACING THE SAMPLE PROBES, SAMPLE ARM TUBING, REAGENT PROBES, REAGENT ARM TUBING, CUVETTE DRYER TIPS, AND THE ICT MODULE/PROBE. THIS ISSUE WAS INVESTIGATED BY REVIEWING THE COMPLAINT HISTORY FOR THE CUSTOMER'S AEROSET, AND BY REVIEWING LABELING IN THE AEROSET SYSTEM OPERATIONS MANUAL LN 09D06-05 (200154-101, 200155-101, NOV 2004). ULTIMATELY, THE ERRATIC RESULT ISSUE APPEARS TO HAVE BEEN A FLUIDICS ISSUE THAT FIELD SERVICE RESOLVED BY REPLACING MULTIPLE PARTS, WHICH WERE EITHER WORN, CLOGGED, CRIMPED, OR MISALIGNED. ALTHOUGH THE ICT MODULE WAS REPLACED, THE INVESTIGATION DOES NOT SUPPORT THAT THE ICT MODULE CONTRIBUTED TO THE ISSUE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED PTS HAVE GENERATED LOW ICT RESULTS ON THE AEROSET ANALYZER, BUT UPON REPEAT, THE RESULTS ARE NORMAL. ONE PT GENERATED A POTASSIUM RESULT OF 1.0 MMOL/L AND WHEN RETESTED, THE RESULT WAS WITHIN NORMAL RANGE. THE LOW RESULT WAS NOT REPORTED AND THERE WAS NO IMPACT TO PT MGMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROSET ANALYZER AUTOMATED CHEMISTRY ANALYZER CGZ ABBOTT MFG INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AEROSET CBK ICT MODULE, LIST 9D28-03