BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

    MDR report key: 3863655 · Received June 10, 2014

    Report

    Report Number
    1319808-2014-00013
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JIX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS K QUALITY CONTROL RESULTS USING A SUB-OPTIMAL CALIBRATION ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THERE WAS NO INDICATION THAT AN INSTRUMENT ISSUE OR A REAGENT ISSUE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE FOR HIGHER THAN EXPECTED K QUALITY CONTROL RESULTS IS USER ERROR ASSOCIATED WITH IMPROPER CALIBRATOR RECONSTITUTION.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS K QUALITY CONTROL RESULTS (N2763= 4.47 VS. EXPECTED 2.80 MMOL/L; BIORAD 1= 6.81 VS. EXPECTED 2.66 MMOL/L) WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT THAT PATIENT SAMPLES WERE AFFECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338567 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 IN VITRO DIAGNOSTICS JIX ORTHO-CLINICAL DIAGNOSTICS 233

    Patients

    Seq Age Sex Outcome Treatment
    1