BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2020631 · Received March 16, 2011

    Report

    Report Number
    1628664-2011-00112
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 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). AN EVALUATION WAS PERFORMED WHICH INCLUDED REVIEW OF COMPLAINT INFORMATION, INSTRUMENT HISTORY, FIELD COMPLAINT REVIEW, AND REVIEW OF ASSOCIATED LABELING. THE CUSTOMER REPLACED THE ARCHITECT I2000SR PROBE SINCE IT WAS APPROXIMATELY 4 MONTHS OLD. THE OPERATOR VALIDATED THE BHCG ASSAY BY PERFORMING REPRODUCIBILITY TESTS. HE PERFORMED THE APPROPRIATE TROUBLESHOOTING STEPS AND THE COMPLAINT ISSUE WAS RESOLVED. QUALITY METRICS WERE REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE CUSTOMER ISSUE. BASED UPON THE AVAILABLE INFORMATION ALONG WITH THE RESULTS OF THIS PRODUCT EVALUATION OF THE ARCHITECT I2000SR SYSTEM, NO PRODUCT DEFICIENCY OF THE ARCHITECT I2000SR INSTRUMENT WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A POSITIVE ARCHITECT BHCG RESULT OF 30 MIU/ML WAS GENERATED FOR A PATIENT SAMPLE THAT RETESTED NEGATIVE AT <1.2 MIU/ML THREE TIMES. CONTROLS WERE WITHIN RANGE. THE PATIENT SAMPLE TESTED PRIOR TO THIS SAMPLE HAD A HIGH BHCG CONCENTRATION OF 100,000 MIU/ML. THE CUSTOMER CHANGED THE SAMPLE PROBE ON THE ARCHITECT (B)(4) TO RESOLVE THE ISSUE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT BHCG REAGENT LIST 7K78-25, LOT 94908JN00| ARCHITECT BHCG REAGENT LIST 7K78-25, LOT 94908JN00