BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    MDR report key: 2882673 · Received December 20, 2012

    Report

    Report Number
    3007111389-2012-00258
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 3, 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 RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES RUN ON THE VITROS 5600 SYSTEM. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS AND REPLACED THE SAMPLE METERING PUMP SUBSYSTEM OF THE ANALYZER. PRECISION TESTING FOLLOWING SERVICE VERIFIED THAT THE EQUIPMENT WAS RETURNED TO EXPECTED OPERATION. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. HOWEVER, SAMPLE PROCESSING, ANALYZER PERFORMANCE OR REAGENT PERFORMANCE COULD NOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (PATIENT (B)(6) = 0.175 VS. EXPECTED RESULT <0.012 NG/ML; PATIENT (B)(6) = 0.193 VS. AN EXPECTED RESULT<0.012 NG/ML) FROM MULTIPLE PATIENT SAMPLES RUN ON THE VITROS 5600 SYSTEM. PATIENT (B)(6) RESULT WAS REPORTED FROM THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, PATIENT 1 SAMPLE WAS REPEAT TESTED. CORRECTED REPORT WAS ISSUED FOR PATIENT (B)(6). PATIENT (B)(6) SAMPLE WAS REPEATED PRIOR TO REPORTING PER CUSTOMER POLICY. 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 IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1060

    Patients

    Seq Age Sex Outcome Treatment
    1