BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2223811 · Received August 26, 2011

    Report

    Report Number
    2122870-2011-02755
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT THE FIELD SERVICE ENGINEER (FSE) DID NOT PERFORM HARDWARE VERIFICATION AT THAT TIME. THE SUSPECT REAGENT PACKS WERE DISPATCHED TO BECKMAN COULTER INC. FOR EVALUATION, HOWEVER AT THE TIME OF THIS FILING HAD NOT YET BEEN RECEIVED/PROCESSED. NO DEFINITIVE ROOT CAUSE HAS BEEN DETERMINED FOR THIS EVENT TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THREE NO-VALUE GI MONITOR QUALITY CONTROL RESULTS, WITH ACCOMPANYING INSTRUMENT FLAGS, WERE GENERATED FROM A UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM UTILIZING A SPECIFIC REAGENT LOT. DATA SUPPLIED FROM THE CUSTOMER INDICATED THAT THREE NO-VALUE GI MONITOR LEVEL 1 QUALITY CONTROL (QC) RESULTS WITH ASSOCIATED IND (INDETERMINATE) INSTRUMENT FLAGS WERE GENERATED ON (B)(6) 2011. ADDITIONALLY, TWO QC TESTS PRODUCED NUMERICAL RESULTS, HOWEVER THESE RESULTS WERE BELOW THE NORMAL REFERENCE RANGE OF THE ASSAY. AN INDETERMINATE SYSTEM FLAG IS INDICATIVE OF A RESULT THAT CANNOT BE DISTINGUISHED FROM A SYSTEM FAILURE. TWO OF THE NO-VALUE GI MONITOR QC RESULTS WERE ASSOCIATED WITH GI MONITOR REAGENT LOT NUMBER 023781, REAGENT PACK 11086. ONE OF THE NO VALUE RESULTS, AND THE TWO LOW NUMERICAL RESULTS, WERE ASSOCIATED WITH GI MONITOR REAGENT LOT NUMBER 023781, REAGENT PACK 11087. THE REAGENT PACKS WERE REMOVED FROM THE INSTRUMENT AND UPON INSPECTION, IT IS ALLEGED THAT THEY APPEARED TO HAVE AN EXTRA ELASTOMER SEAL ATTACHED TO THEM. DATA SUPPLIED BY THE CUSTOMER INDICATES THAT THIS EVENT WAS LIMITED TO QUALITY CONTROL RESULTS ONLY. NO PATIENT RESULTS WERE AFFECTED AND NO IMPACTED RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE HAVE BEEN NO REPORTS OF DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT GI MONITOR QUALITY CONTROL RESULTS UTILIZING A NEW GI MONITOR REAGENT LOT RECOVERED WITHIN CUSTOMER ESTABLISHED SPECIFICATION AFTER THE EVENT. NO PATIENT SPECIFIC INFORMATION OR SAMPLE COLLECTION /HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS GI MONITOR REAGENT