BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    MDR report key: 167733 · Received May 12, 1998

    Report

    Report Number
    2250051-1998-00060
    Event Type
    Other
    Date Received
    May 12, 1998
    Date of Event
    April 14, 1998
    Report Date
    May 4, 1998
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RUNNING AN ANTIBODY SCREENING ASSAY, SUMMIT SAMPLE HANDLER DID NOT PIPETTE SAMPLE IN ROW 2 AND DID NOT GIVE AN ERROR MESSAGE. AN ORTHO FIELD SVC ENGINEER WAS DISPATCHED. NO REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC COMPLAINT NUMBER 98-01757-04.

    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