BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 2910946 · Received January 11, 2013

    Report

    Report Number
    1415939-2013-00008
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    December 21, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MMI
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS SUBMITTED UNDER THE INCORRECT MANUFACTURE SITE OF ABBOTT (B)(4) AND SHOULD HAVE BEEN (B)(4). MDR NUMBER 1628664-2013-00022 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT I2000 ANALYZER GENERATED A FALSE POSITIVE TROPONIN RESULT. THE SAMPLE WAS REPEATED IN DUPLICATE AND NEGATIVE RESULTS WERE GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16995 ARCHITECT I2000SR ANALYZER MMI ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT TROPONIN 2K41-28 LOT UNKNOWN| ARCHITECT TROPONIN 2K41-28 LOT UNKNOWN