BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAMS/MIDAS PROTOCOL DISKETTE

    MDR report key: 57529 · Received December 13, 1996

    Report

    Report Number
    2250051-1996-00035
    Event Type
    Malfunction
    Date Received
    December 13, 1996
    Date of Event
    November 21, 1996
    Report Date
    December 13, 1996
    Manufacturer
    ORTHO DIAGNOSTIC SYSTEMS, INC
    Product Code
    JTC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A CO'S SERVICE ENGINEER ON SITE REPORTED THAT THERE IS RESIDUAL POSITIVE CONTROL CLINGING TO PIPETTE TIPS AFTER DISPENSING 50 UL OF POSITIVE CONTROL DURING AN HIV-1 P24 ANTIGEN ASSAY. THE ROOT CAUSE HAS BEEN DETERMINED TO BE THE SOFTWARE, DISKETTE VERSION 2.0. INVESTIGATION HAS SHOWN THAT THE SOFTWARE INSTRUCTS THE SUMMIT SAMPLE HANDLER TO DISPENSE THE INITIAL 50 UL OF POSITIVE CONTROL AT AN INCORRECT HEIGHT. THIS CAUSED A DROPLET TO BE POSSIBLY LEFT ON THE END OF THE TIP. NO DEATH OR SERIOUS INJURY HAS BEEN ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAMS/MIDAS PROTOCOL DISKETTE MEDICAL DEVICE SOFTWARE JTC ORTHO DIAGNOSTIC SYSTEMS, INC NA VERSION 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other