BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM

    MDR report key: 120216 · Received September 15, 1997

    Report

    Report Number
    2250051-1997-00087
    Event Type
    Other
    Date Received
    September 15, 1997
    Date of Event
    August 21, 1997
    Report Date
    September 15, 1997
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A WHILE RUNNING AN HTLV-I ASSAY, SUMMIT SAMPLE HANDLER, PIPETTED A BUBBLE INTO A WELL IN ROW H AND DID NOT GIVE AN ERROR MESSAGE. AN ORTHO FIELD SERVICE ENGINEER WAS DISPATCHED. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO DIAGNOSTIC SYSTEMS COMPLAINT NUMBER 97-04242-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM SAMPLE HANDLER JTC HAMILTON BONADUZ AG 135028 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other