BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3264857 · Received August 5, 2013

    Report

    Report Number
    1628664-2013-00193
    Event Type
    Malfunction
    Date Received
    August 5, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 4, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL DATA AND INFORMATION WAS PROVIDED ON 13AUG 2013. THE CUSTOMER OBSERVED DISCREPANT (WHICH WAS ORIGINALLY INCORRECTLY THOUGHT TO BE FALSE (B)(6), BUT WAS CONFIRMED WITH THE CUSTOMER TO BE (B)(6)) DATA FOR THE PATIENT FOR (B)(6) IGG ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) INITIAL RESULT (B)(6) 11.74 S/CO REPEAT NONREACTIVE 0.08 S/CO THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. PLEASE NOTE THE INCORRECT SID NUMBER WAS SUBMITTED IN THE INITIAL REPORT AS SID (B)(6), BUT THIS IS THE SAME PATIENT. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT. THIS IS NO LONGER A REPORTABLE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE POSITIVE HAVAB IGG RESULTS (FOR UP TO 10 PATIENTS, BUT DATA WAS PROVIDED FOR ONLY 1) ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID 7002219 INITIAL 11.74 S/CO, REPEAT 0.08 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THE CUSTOMER BELIEVES THE ISSUE IS RELATED TO THE WASH BUFFER TRANSFER TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365226 ARCHITECT I2000SR ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT HAVAB IGG| UNKNOWN LOT NUMBER AND LIST NUMBER| UNKNOWN LOT NUMBER AND LIST NUMBER| ARCHITECT HAVAB IGG