BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APS INPUT OUTPUT MODULE

    MDR report key: 2251812 · Received September 16, 2011

    Report

    Report Number
    1628664-2011-00617
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PREVIOUS REPORT WITH THE REPORT NUMBER OF 1628664-2011-00535 WAS SUBMITTED FOR THIS ISSUE. HOWEVER, THE PREVIOUS REPORT WAS AGAINST THE ARCHITECT (B)(4) ANALYZER LN 03M74-02 SN (B)(4) WHICH WAS CHANGED AND IT WAS DETERMINED THIS ISSUE TO BE RELATED TO THE APS INPUT OUTPUT MODULE. THE MANUFACTURER REPORT NUMBER FOR THE REPORT SUBMITTED AGAINST THE APS IOM IS 1628664-2011-00617. TO EVALUATE THIS ISSUE, A FIELD SERVICE REPRESENTATIVE INSPECTED THE PRODUCT , CHANGED THE SAMPLE ANTENNA AND VERIFIED PROPER OPERATION. SYSTEM LOGS WERE NOT AVAILABLE FOR REVIEW AND THEREFORE, A SAMPLE QUEUE ERROR COULD NOT BE CONFIRMED TO BE GENERATED WITHOUT A SAMPLE PRESENTATION ERROR ON THE PRIOR SAMPLE. CURRENT LABELING DESCRIBES THE GENERATION OF A SAMPLE PRESENTATION ERRORS AND SAMPLE QUEUE ERROR ALONG WITH THE CORRECTIVE AND PREVENTIVE ACTIONS. THE CUSTOMER TOOK THE PROPER CORRECTIVE ACTION BY RERUNNING THE SAMPLE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY OR MALFUNCTION WERE IDENTIFIED AS A RESULT OF THE PRODUCT EVALUATION.

    Description of Event or Problem · 1

    WHILE PROCESSING ONE PATIENT SAMPLE ((B)(6)) ON THE ARCHITECT ANALYZER, THE CUSTOMER OBSERVED THE ERROR MESSAGE OF SQE (SAMPLE QUEUE ERROR) WHICH COULD CAUSE SAMPLE IDENTIFICATION MISMATCH ISSUE. THE CUSTOMER RERAN THE PATIENT SAMPLE TO AVOID CONTAMINATING THE SAMPLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APS INPUT OUTPUT MODULE JQP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1