BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 3124888 · Received May 22, 2013

    Report

    Report Number
    1319681-2013-00108
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 250 CHEMISTRY SYSTEM. AN OCD FIELD ENGINEER PERFORMED ¿AS NEEDED¿ MAINTENANCE ACTIVITIES AND RECALIBRATED THE SAME REAGENT LOT TO RETURN VITROS AMON TO EXPECTED PERFORMANCE. THE MOST LIKELY CAUSE OF THE EVENT WAS DETERMINED TO BE INSTRUMENT RELATED. THERE WAS NO EVIDENCE THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS AMON QUALITY CONTROL RESULTS ON A VITROS 250 CHEMISTRY SYSTEM. QC FLUID LOT C1730 = 93 VS. AN EXPECTED RESULT = 46.2 MMOL/L; QC FLUID LOT D1731 = 236 VS. AN EXPECTED RESULT = 194 MMOL/L; 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 OR REPORTED FROM THE LABORATORY. 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
    226310 VITROS 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1