BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8208716 · Received January 2, 2019

    Report

    Report Number
    1319681-2018-00133
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 5, 2018
    Report Date
    January 2, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT HIGHER THAN EXPECTED VITROS CK-MB RESULTS WERE OBTAINED USING A NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUID IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. INSTRUMENT CONTAMINATION WITH BLEACH IS THE MOST LIKELY ASSIGNABLE CAUSE OF THE ISSUE, AS AN ORTHO FIELD ENGINEER (FE) FOUND THERE WAS BLEACH IN THE AREA ON THE INSTRUMENT. AFTER THE SYSTEM WAS CLEANED AND PURGED, FILTERS, PURGED AIR LINES, SIGNAL REAGENT PROBES AND UNIVERSAL WASH FLUID WERE REPLACED THE INSTRUMENT WAS RETURNED TO EXPECTED OPERATION. THE CUSTOMER CHANGED TO A NEW LOT OF REAGENT, THEREFORE, REAGENT PERFORMANCE COULD NOT BE VERIFIED. CK-MB REAGENT PERFORMANCE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS CK-MB RESULTS USING A NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUID IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. NON-VITROS BIORAD QC FLUID LOT 23691 CK-MB RESULTS OF 4.68, 4.71, AND 4.54 NG/ML VERSUS AN EXPECTED RESULT OF 3.15 NG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS CK-MB RESULTS WERE OBTAINED WHEN PROCESSING A QC FLUID. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3635 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1