BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1030588 · Received April 16, 2008

    Report

    Report Number
    1628664-2008-00094
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    February 22, 2008
    Report Date
    April 4, 2008
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    LOJ
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CUSTOMER STATES THAT DISCREPANT AFP RESULTS WERE GENERATED USING THE ARCHITECT AFP ASSAY. THE INSTRUMENT WAS EVALUATED BY A FIELD SVC REP AND THE TRIGGER/PRE-TRIGGER VALVE FUNCTION WAS OBSERVED. THE TRIGGER DRAIN VALVE WAS NOT FUNCTIONING CORRECTLY. THE MANIFOLD VALVE WAS REPLACED AND THE VALVE TEST PASSED. TRENDING: A REVIEW OF COMPLAINTS WAS PERFORMED FOR THE TIME PERIOD OF 2008. NO TRENDS RELATED TO AFP RESULTS WERE FOUND. LABELING: THE EVENT IS ADDRESSED IN THE ABBOTT ARCHITECT SYS OPERATIONS MANUAL (WITH C16000) SECTION 10-555 (PN 201837-102) OCTOBER, 2006 TROUBLESHOOTING AND DIAGNOSTICS SECTION 10 SAMPLE RESULTS OBSERVED PROBLEMS (I SYS) ERRATIC ASSAY RESULTS (I SYS). THIS PROBLEM MAY BE OBSERVED ON AN ARCHITECT I SYS. PROBABLE CAUSE; SYRINGE ASSEMBLIES OR VALVES ARE LEAKING. CORRECTIVE ACTION; CHECK FOR SALT CRYSTALS AND/OR LIQUID AROUND ALL SYRINGES OR VALVES. CONTACT YOUR AREA CUSTOMER SUPPORT IF CRYSTALS OR LIQUID ARE OBSERVED. CONCLUSION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ANALYSIS OF LABELING WAS PERFORMED. A COMPONENT/SUBASSEMBLY FAILURE (VALVE) ON THE DEVICE WAS FOUND TO BE MALFUNCTIONING CONTRIBUTING TO THE EVENT. THE MANIFOLD VALVE WAS REPLACED AND THE VALVE TEST PASSED RESOLVING THE ISSUE. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED DUE TO THIS EVENT. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT UNEXPECTED HIGH RESULT WAS GENERATED FOR A PT SAMPLE TESTED USING THE ARCHITECT AFP ASSAY THAT WHEN REPEATED, A LOWER RESULT WAS OBTAINED. NO IMPACT TO PT MANAGEMENT WAS REPORTED. PT RESULTS: INITIAL RESULT 12.36 NG/ML, REPEAT RESULT 4.13 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER CMIA-AUTOMATED ANALYZER LOJ ABBOTT MANUFACTURING INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT AFP REAGENT LIST # 7K67-30 LOT # UNK