BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 4242324 · Received November 11, 2014

    Report

    Report Number
    1319681-2014-00178
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 2, 2014
    Report Date
    November 11, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS GENT AND VALP QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS AN INSTRUMENT ISSUE RELATED TO THE PHOTOMETER SUBSYSTEM OF THE MICRO TIP SUBSYSTEM OF THE VITROS 5600 INSTRUMENT. PERFORMING ROUTINE MAINTENANCE TO THE PHOTOMETER SUBSYSTEM RESOLVED THE ISSUE. THERE WAS NO INDICATION THE VITROS GENT OR VALP REAGENTS MALFUNCTIONED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE OCD TECHNICAL SOLUTION CENTER (TSC) TO REPORT VITROS GENTAMICIN (GENT) AND VALPROIC ACID (VALP) QUALITY CONTROL RESULTS WERE HIGHER THAN EXPECTED WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. GENT RESULTS >10.0 AND 9.84 UG/ML VS. EXPECTED 7.45 UG/ML. VALP RESULT OF 142.1 UG/ML VS. EXPECTED 118.0 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS WERE AFFECTED, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED DURING THE TIMEFRAME OF THE EVENT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727277 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1