BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 7247053 · Received February 7, 2018

    Report

    Report Number
    1319809-2018-00009
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    December 15, 2017
    Report Date
    August 9, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED HIGHER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM VITROS AND NON-VITROS QUALITY CONTROL FLUIDS, USING TWO DIFFERENT SLIDE LOTS OF VITROS PHYT SLIDES TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENTS. THE ISSUE OCCURRED WHEN TWO NEW VITROS PHYT SLIDE LOTS WERE PUT INTO USE, AND NO OTHER IMMUNORATE ASSAYS WERE AFFECTED. THEREFORE, AN ISSUE WITH THE VITROS PHYT SLIDE LOTS IN USE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. AN ISSUE RELATED THE VITROS INSTRUMENT PERFORMANCE CANNOT BE ELIMINATED, AS SEVERAL VITROS PHYT PRECISION TEST RESULTS WERE OUTSIDE OF ACCEPTABLE GUIDELINES AND THE ISSUE WAS ACROSS SEVERAL VITROS PHYT SLIDE LOTS.

    Additional Manufacturer Narrative · 1

    A POTENTIAL ISSUE RELATED TO THE ABSOLUTE RESPONSE RATES AND THE DOSE RESPONSE CURVE OF PHYT COATING 0165 IS BEING INVESTIGATED. THE FDA¿S NEW YORK DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON (B)(4) 2018. PLEASE REFER TO REPORT # (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED MULTIPLE HIGHER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM VITROS AND NON-VITROS QUALITY CONTROL FLUIDS, USING TWO DIFFERENT SLIDE LOTS OF VITROS PHYT SLIDES TESTED ON A VITROS 5600 INTEGRATED SYSTEM. (B)(6). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR UNDETECTED. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY; HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF SIX MDR¿S FOR THIS EVENT, AS SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90379 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2616-0165-6275

    Patients

    Seq Age Sex Outcome Treatment
    1