BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 7073215 · Received November 30, 2017

    Report

    Report Number
    1628664-2017-00469
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 30, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740006235
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE ACCOUNT AND REPLACED THE MANIFOLD KIT VALVE [PART 7-77612-03] AND VACUUM VESSEL VALVE, DRAIN [PART 7-76447-01]. THESE PARTS WERE CONSIDERED THE LIKELY CAUSE OF THE CUSTOMER ISSUE. THE FSE PERFORMED A CONTROL RUN AND THE ANALYZER WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A LABELING REVIEW, DEVICE HISTORY REVIEW, AND AN INSTRUMENT SERVICE REVIEW. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE IN A 12 MONTH PERIOD FOR SIMILAR COMPLAINTS THAT INCLUDED THE REPLACED PARTS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH REPLACEMENT OF PARTS, INCLUDING MANIFOLD KIT VALVE [PART 7-77612-03] AND VACUUM VESSEL VALVE, DRAIN [PART 7-76447-01]. DEVICE HISTORY REVIEW FOR REPLACED PARTS, MANIFOLD KIT VALVE [PART 7-77612-03] AND VACUUM VESSEL VALVE, DRAIN [PART 7-76447-01], DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. SERVICE HISTORY REVIEW IDENTIFIED ONE ADDITIONAL ISSUE FOR THE SAME CUSTOMER. THE ADDITIONAL ISSUE WAS RELATED TO A SINGLE FALSE POSITIVE TOTAL B-HCG RESULT THAT WAS RECEIVED ON NOVEMBER 18, 2017. THIS ISSUE WAS RESOLVED BY REPLACEMENT OF THE WZ MANIFOLD, FEP TIPS [PART 7-96176-05]. NO CONTRIBUTING FACTORS TO THE CUSTOMER ISSUE WERE IDENTIFIED AND NO ADDITIONAL DISCREPANT RESULTS WERE REPORTED BY THE CUSTOMER. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS EVALUATION, NO SYSTEMIC ISSUE WAS IDENTIFIED AND NO PRODUCT DEFICIENCY WAS FOUND. CONCOMITANT MEDICAL PRODUCTS: THE CUSTOMER WAS USING ARCHITECT TOTAL B-HCG REAGENT LN 7K78-25/-26 LN 76055LI00 OR LN 7K78-35 LN 76054UI00 WITH THE COMPLAINT ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY POSITIVE BETA HUMAN CHORIONIC GONADOTROPIN (B-HCG) RESULTS FOR ONE PATIENT WHILE USING THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING RESULTS WERE PROVIDED. SID (B)(6) INITIAL 419 MIU/ML (POSITIVE), REPEAT LESS THAN 1.2 (NEGATIVE). REPEAT USING THE SAME ANALYZER AND ANOTHER ANALYZER WERE NEGATIVE, HOWEVER THE SPECIFIC VALUES WERE NOT PROVIDED. THE PATIENT HAD BEEN TAKING MEDICATION SIMVASTATIN REGULARLY. THE CUSTOMER STATED THAT THE MEDICATION WAS NOT GIVEN OR WITHHELD DUE TO THE FALSELY ELEVATED RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852010 ARCHITECT I2000SR ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740006235

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR