BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2882219 · Received December 20, 2012

    Report

    Report Number
    1319681-2012-00246
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    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 TROP I ES QUALITY CONTROL RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES RUN ON 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 (TROP I ES RESULTS= 0.071, 0.087, 0.448, 0.343, 0.231, 0.340, 0.112 VS. EXPECTED RESULTS <0.012 NG/ML AND TROP I ES RESULTS= 0.327, 0.412, 0.139 VS. EXPECTED RESULTS= 0.020 NG/ML) FROM MULTIPLE PATIENT SAMPLES RUN ON THE VITROS 5600 SYSTEM. THE AFFECTED RESULTS WERE REPORTED FROM THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT SAMPLES WERE REPEATED. CORRECTED REPORTS WERE ISSUED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR'S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1