BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS IMMUNO-WASH FLUID

    MDR report key: 2986487 · Received March 4, 2013

    Report

    Report Number
    1319808-2013-00016
    Event Type
    Malfunction
    Date Received
    March 4, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED VITROS PHYT QUALITY CONTROL RESULTS AND A SINGLE PATIENT RESULT WERE OBTAINED WHILE USING A VITROS 350 CHEMISTRY SYSTEM. THE CSC DETERMINED THAT THE CUSTOMER WAS NOT INVERTING IWF RESERVOIRS PRIOR TO LOADING THEM ONTO THE VITROS 350 CHEMISTRY SYSTEM, AS RECOMMENDED IN THE IFU. ACCEPTABLE PERFORMANCE HAS BEEN OBSERVED SINCE THE CSC REVIEWED PROPER IWF HANDLING PROTOCOL WITH THE CUSTOMER. THE MOST LIKELY ROOT CAUSE OF THE EVENT IS USER ERROR DUE TO IMPROPER IWF HANDLING. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE, NON-REPRODUCIBLE, UNEXPECTED VITROS PHYT QUALITY CONTROL RESULTS AND A SINGLE PATIENT RESULT WHILE USING A VITROS 350 CHEMISTRY SYSTEM. QC FLUID LOT A1565 = 16.22, 16.41 VS. EXPECTED RESULT = 13.40 UG /ML; QC FLUID LOT B1567 = 16.79, 16.86, 17.32, 17.49, 15.65, 17.30, 17.02, 16.64, 16.55, 17.56, 29.13, 28.62, 41.85, 39.91 VS. EXPECTED RESULT = 22.70 UG /ML; PATIENT RESULT = 15 VS. AN EXPECTED RESULT = 25 UG /ML. THE AFFECTED PATIENT RESULT WAS REPORTED OUT OF THE LABORATORY. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. DUE TO THE UNEXPECTED PHYT QUALITY CONTROL RESULTS, THE AFFECTED PATENT SAMPLE WAS REPEAT TESTED AND A CORRECT REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91987 VITROS CHEMISTRY PRODUCTS IMMUNO-WASH FLUID IN-VITRO DIAGNOSTIC JJE ORTHO-CLINICAL DIAGNOSTICS A2464

    Patients

    Seq Age Sex Outcome Treatment
    1