BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 2171885 · Received July 22, 2011

    Report

    Report Number
    1628664-2011-00537
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. (B)(4). FALSE POSITIVE RESULT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED BOTH REAGENT 1 (R1) AND REAGENT (2) PROBES AND SWAPPED VORTEXERS 1 AND 3. AN ABBOTT FIELD SERVICE ENGINEER (FSE) AT THE SITE ALSO CLEANED VORTEXERS 1, 2 AND 3, CLEANED THE CUP LOADER/UNLOADER, REPLACED THE SYRINGE VALVE OF THE R1 PIPETTOR, REPLACED THE R1 AND R2 SAMPLE PROBES, CALIBRATED THE SAMPLE, R1, AND R2 SAMPLE PIPETTORS, AND PERFORMED DAILY MAINTENANCE. BASED UPON THE DATA AVAILABLE, AND THE RESULTS OF THIS EVALUATION OF THE ARCHITECT I2000SR SYSTEM, A SINGLE DEFINITIVE CAUSE FOR THE CUSTOMER'S ISSUE COULD NOT BE DETERMINED. NO PRODUCT DEFICIENCY OF THE ARCHITECT I2000SR INSTRUMENT WAS FOUND. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT SYSTEM OPERATIONS MANUAL (PN 201837-108), JANUARY 2010 AND THE TOTAL BHCG PACKAGE INSERT (49-3364\R3) JUNE 2010 CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED A FALSE POSITIVE ARCHITECT TOTAL B-HCG ASSAY RESULT. THE SAMPLE INITIALLY GENERATED A RESULT OF LESS THAN 2.0 MIU/ML. THE SAMPLE RETESTED AT 2500 MIU/ML. THE SAMPLE RETESTED AT LESS THAN 1.0 MIU/ML ON A NON-ABBOTT PLATFORM. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH TOTAL B-HCG LN: 7K78-30| ARCHTOT B-HCG LN:07K78-30 LOT:01918JN00| ARCHTOT B-HCG LN:07K78-30 LOT:01918JN00