BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3093254 · Received May 5, 2013

    Report

    Report Number
    1628664-2013-00113
    Event Type
    Malfunction
    Date Received
    May 5, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLE SHOOTING REVEALED THAT THE TRIGGER STRAW WAS CRACKED AND NOT FULLY SEATED. THE STRAW WAS REPLACED AND SEATED CORRECTLY AND THE ISSUE WAS RESOLVED. (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. THE CUSTOMER INDICATED THE DISCREPANT RESULTS WERE DUE TO THE TRIGGER LEVEL SENSE SENSOR (LIST NUMBER 08C94-26) BEING CRACKED, AND NOT FULLY SEATED. THE ISSUE WAS RESOLVED BY REPLACING AND CORRECTLY SEATING THE TRIGGER LEVEL SENSE SENSOR (LIST NUMBER 08C94-26). THE ISSUE IN QUESTION IS ADEQUATELY ADDRESSED IN PRODUCT LABELING. NO TRENDS FOR TICKET WITH REPLACEMENTS FOR THE TRIGGER LEVEL SENSE SENSOR (08C94-26) WERE IDENTIFIED. BASED ON THE EVALUATION RESULTS, NO DEFICIENCY WAS IDENTIFIED TO BE RELATED TO THE MALFUNCTION REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED LOW RESULTS FLAGGED WITH (<). THE CUSTOMER SPECIFIED SEVERAL ASSAYS LIKE BNP AND FERRITIN (NO SPECIFIC DATA WAS PROVIDED). HOWEVER, THE CUSTOMER PROVIDED AN EXAMPLE OF A TROPONIN RESULT (<32 NG/L- NEGATIVE) GENERATED FROM ONE PATIENT SAMPLE. THE SAME SAMPLE WAS RETESTED ON ANOTHER ANALYZER WITH A POSITIVE RESULT OF 6,000 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195844 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 TROPONIN 02K41| TROPONIN 02K41