BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 287358 · Received July 24, 2000

    Report

    Report Number
    2250051-2000-00185
    Event Type
    Malfunction
    Date Received
    July 24, 2000
    Date of Event
    June 8, 2000
    Report Date
    June 29, 2000
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING AN HIV-1 P24 ANTIGEN ASSAY, SUMMIT SAMPLE HANDLER DID NOT PIPETTE THE CORRECT AMOUNT OF LYSE BUFFER IN WELL POSITIONS B9, C9 AND D9 AND DID NOT GIVE AN ERROR MESSAGE. AN ORTHO FIELD SERVICE ENGINEER WAS DISPATCHED AND DUPLICATED THE PROBLEM. THE FSE REPLACED ALL TIP CLAMPS AND COMPRESSION SPRINGS AND INSPECTED ALL PLUNGER CLAMPS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS COMPLAINT NUMBER 00-03251-06.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other