BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1191943 · Received October 9, 2008

    Report

    Report Number
    1628664-2008-00232
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETED, RESULTS AND CONCLUSION CODES CANNOT BE DRAWN. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS PERFORMED IN RESPONSE TO THE COMPLAINT OF AXSYM PLUS ANALYZER (B)(4) GENERATING HIGH CONTROL RESULTS, AND DISCREPANT PATIENT RESULTS. THE INVESTIGATION OF THE ISSUE CONSISTED OF A REVIEW OF CUSTOMER COMPLAINTS, CURRENT AXSYM LABELING, AND THE INFORMATION PROVIDED INCLUDING THE COMPLAINT TEXT. THE COMPLAINT INFORMATION NOTES THE FIELD SERVICE REPRESENTATIVE REPLACED THE PROCESSING PROBE TUBING, PM SYRINGE TUBING, PM SENSOR KIT, PM PROBE TUBING, AND THE SOLUTION 3 (B)(4) ON AXSYM (B)(4) ON (B)(6) 2008. A COMPLAINT REVIEW FOUND THERE HAVE BEEN NO ADDITIONAL INCIDENTS OF DISCREPANT RESULT GENERATION BY AXSYM (B)(4), SINCE THE TUBING, PM SENSOR KIT, AND SOLUTION 3 (B)(4) WERE REPLACED. REFERENCE WHERE IN LABELING THE EVENT IS ADDRESSED: MANUAL REVIEW: THE AXSYM SYSTEM OPERATION MANUAL ((B)(4)) WAS REVIEWED AND WAS FOUND TO CONTAIN ADEQUATE INFORMATION ON TROUBLESHOOTING HIGH CONTROL RESULTS, TROUBLESHOOTING DISCREPANT RESULTS, AND ON ELECTRICAL HAZARDS. TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, (B)(4) RESULTS TOO HIGH LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR HIGH RESULT GENERATION. THESE PROBABLE CAUSES INCLUDE BULK SOLUTION 3 NOT DISPENSING PROPERLY, MALFUNCTION OF THE SAMPLING AND PROCESS SYRINGE, VALVE, PROBE AND TUBING. THE CORRECTIVE ACTIONS INCLUDE VERIFYING PROPER BULK SOLUTION 3 DISPENSE AND REPLACING DAMAGED OR LEAKING TUBING. TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, RESULTS ERRATIC, DISCREPANT, AND/OR EXPERIENCING IMPRECISION LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR DISCREPANT RESULTS. THE PROBABLE CAUSES LISTED INCLUDE MALFUNCTIONING SAMPLING AND PROCESSING SYRINGE, VALVE, PROBE AND TUBING, AND BULK SOLUTION 3 DISPENSING IMPROPERLY. CORRECTIVE ACTIONS LISTED INCLUDE REPLACING DAMAGED OR LEAKING TUBING, AND VERIFYING BULK SOLUTION 3 DISPENSE. OPERATIONAL PRECAUTIONS AND LIMITATIONS, HAZARD TYPES NOTES THE AXSYM SYSTEM POSES NO UNCOMMON ELECTRICAL SHOCK HAZARDS TO OPERATORS IF THE ANALYZER IS INSTALLED WITHOUT ALTERATION AND CONNECTED TO A POWER SOURCE OF REQUIRED SPECIFICATIONS. THIS SECTION OF THE MANUAL ALSO NOTES KEEP LIQUIDS AWAY FROM ALL CONNECTORS OF ELECTRICAL COMPONENTS. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED DISCREPANT RESULTS WITH THE AXSYM ANALYZER FOR DIGOXIN III AND BHCG ASSAYS. THE ACCOUNT STATED THEY REPORTED AN AXSYM DIGOXIN III = <0.3 (NO UNITS OF MEASUREMENT PROVIDED). THE SPECIMEN WAS REPEATED WITH AN AXSYM DIGOXIN III = 1.2 (NO UNITS OF MEASUREMENT WERE PROVIDED). THE ACCOUNT ALSO STATED DISCREPANT RESULTS WERE GENERATED FOR AXSYM BHCG ASSAY ON 5 PATIENTS. NO DATA WAS PROVIDED FOR THE AXSYM BHCG ASSAY. NO PATIENT INFORMATION IS AVAILABLE. THE ACCOUNT STATED THE DISCREPANT AXSYM RESULTS OCCURRED BECAUSE NO SOLUTION WAS COMING THROUGH DISPENSER #3 ON THE AXSYM ANALYZER. WHEN THE LEAK WAS DISCOVERED, THE DIGOXIN QUALITY CONTROL WAS READING ZERO AND THE BHCG QUALITY CONTROL WAS OUT OF RANGE HIGH. ADDITIONALLY, THE ACCOUNT SMELLED A SMOKE SCENT BUT DID NOT OBSERVE ANY FLAMES OR FIRE. THE ACCOUNT TURNED OFF THE AXSYM UNTIL SERVICE ARRIVED. SERVICE DISCOVERED THAT PRESSURE SENSOR ON THE AXSYM ANALYZER WAS LEAKING. SERVICE WAS AT THE ACCOUNT THE PREVIOUS DAY AND INADVERTENTLY FORGOT TO PLUG IN REAGENT #3 WHICH LEAD TO THE LEAK. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED DUE TO THE DISCREPANT RESULTS AND NO INJURY WAS REPORTED, DUE TO THE LEAK ON THE AXSYM ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI DIGOXIN (B)(4)| DIGOXIN (B)(4)