BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2883255 · Received December 21, 2012

    Report

    Report Number
    1319681-2012-00254
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES QUALITY CONTROL RESULTS WERE OBTAINED WHILE USING THE VITROS 5600 SYSTEM. THE ROOT CAUSE OF THIS EVENT IS PARTICULATE FILTER BEING INADVERTENTLY INSTALLED IN THE INSTRUMENT VAC LOCATION. THE EVENT OCCURRED BECAUSE OCD HAD INADVERTENTLY PACKAGED THE PARTICULATE FILTERS IN VAC SALES CARTONS. THE ISSUE WAS NOT DETECTED BY THE USER PRIOR TO USE. FOLLOWING THE REPLACEMENT OF THE PARTICULATE FILTER WITH VAC, VITROS TROP I ES WAS RETURNED TO EXPECTED PERFORMANCE. THE ISSUE HAS BEEN COMMUNICATED TO CUSTOMERS THROUGH CUSTOMER LETTER (B)(4). THE FDA'S (B)(4) DISTRICT OFFICE WILL BE NOTIFIED OF THIS ISSUE BY 21-DECEMBER-2012 PER RECALL NUMBER 1319681-12/XX/2012-001-C.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES QUALITY CONTROL RESULTS RUN ON THE VITROS 5600 SYSTEM. TROP I ES RESULTS= 0.065, 0.064, 0.065, 0.060, 0.060, 0.063, 0.067, 0.059, 0.063, 0.064, 0.059, 0.065, 0.063, 0.062, 0.061, 0.060, 0.056, 0.061, 0.055, 0.049 VS. AN EXPECTED RESULT 0.014 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE RUN DURING THE TIME FRAME OF THE EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1