BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APS INPUT OUTPUT MODULE

    MDR report key: 6635667 · Received June 12, 2017

    Report

    Report Number
    1628664-2017-00254
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Date of Event
    May 22, 2017
    Report Date
    June 23, 2017
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE ENGINEER WAS DISPATCHED TO THE ACCOUNT AND FOUND DAMAGE DUE TO AN APPARENT SPILL WITHIN THE ACCELERATOR AUTOMATED PROCESSING SYSTEM (APS) TUBE STORAGE MODULE. EVIDENCE OF CHARRING WAS FOUND AT THE R30.1 CONNECTION LOCATED AT THE LINMOT TUBE MOTOR DRIVER (8-202280-01) WITHIN THE APS TUBE STORAGE MODULE. THE SMOKE FROM THE MODULE WAS LIMITED TO THIS PART AND DID NOT SPREAD TO OTHER PARTS OF THE EQUIPMENT. THE LINMOT RESISTOR (PART NUMBER 8-202281-01) AND LINMOT TUBE MOTOR DRIVER (8-202280-01) WERE REPLACED TO RESOLVE THE ISSUE. THE ANALYZER WAS RETURNED TO NORMAL OPERATION. EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING, AND DEVICE HISTORY REVIEW. NO RETURNS WERE MADE AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. NO SUBSEQUENT REPORTS OF SMOKE/BURN ISSUES WERE IDENTIFIED. DEVICE HISTORY REVIEW FOR THE APS TUBE STORAGE MODULE DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. NO ADVERSE TREND OR SYSTEMATIC ISSUE WAS IDENTIFIED FOR THE ISSUE IDENTIFIED IN THE COMPLAINT. PRODUCT LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A BURNING SMELL AND SAW SMOKE COMING OUT OF THE ACCELERATOR AUTOMATED PROCESSING SYSTEM (APS) TUBE STORAGE MODULE. THE CUSTOMER TURNED OFF THE TRACK SYSTEM. DURING TROUBLESHOOTING, THE CUSTOMER FOUND THAT A URINE SPECIMEN TUBE HAD FALLEN ONTO THE PARTS THAT APPEARED BURNT. NO FIRE OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414459 APS INPUT OUTPUT MODULE DECISION MANAGER FOR ACCELERATOR JQP ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1