BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VERSEIA® PIPETTER

    MDR report key: 13006362 · Received December 14, 2021

    Report

    Report Number
    2250051-2021-00079
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 14, 2021
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(6). POTENTIALLY DISCREPANT FALSE NEGATIVE RESULTS FOR ONE CONTAMINATED PATIENT SAMPLE WHILE TESTING WITH TWO ORTHO VERSEIAS. THE ROOT CAUSE COULD NOT BE DETERMINED, ALTHOUGH IT COULD NOT BE EXCLUDED TO BE ASSOCIATED WITH CONTAMINATION FROM BLUE SPECIMEN DILUENT DRIPPING INTO THE SAMPLE. NO GENERAL PRODUCT FAILURE IS IDENTIFIED. A BIASED RESULT WAS POTENTIALLY REPORTED TO A PHYSICIAN. REPEAT TESTING REMAINED NEGATIVE. NO PATIENT WAS HARMED AS A RESULT OF THE REPORT EVENTS.

    Description of Event or Problem · 0

    REPORT 2 OF 2. ORTHO ACCOUNT MANAGER (AM) REPORTED THAT ONE DONOR SAMPLE WAS POSSIBLY CONTAMINATED AFTER ALL SIX DONOR SCREENING ASSAYS WERE COMPLETED. ASSAYS WERE PERFORMED USING TWO DIFFERENT VERSEIA ANALYZERS BUT AM COULDN'T PROVIDE DETAILS TO WHICH ASSAY WAS PERFORMED ON WHICH VERSEIA. ACCORDING TO AM, THE PLASMA ON THE DONOR SAMPLE IN QUESTION HAD A "BLUE COLOR" THAT WAS NOT DETECTED UNTIL THE TECH WAS MOVING THE DONOR SAMPLE FROM THE RETESTED RACK TO THE COMPLETE RACK. TESTING WAS PERFORMED FOR SIX ASSAYS AND RESULTS WERE RELEASED BY DONOR CENTER. UPON RETEST, THIS DONOR WAS FOUND TO BE NONREACTIVE WITH ALL ASSAYS TESTED. PROBLEM DESCRIPTION ISSUE WAS OBSERVED ON: OCCURRED ON (B)(6) 2021; REPORTED 02 DEC-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897858 ORTHO VERSEIA® PIPETTER AUTOMATED PIPETTER KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown