BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    MDR report key: 4020691 · Received August 19, 2014

    Report

    Report Number
    3007111389-2014-00187
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 20, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROPI ES RESULTS WERE OBTAINED FROM FOUR PATIENT SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. A VITROS TROPI ES REAGENT CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTOR. ADDITIONALLY, THE SAMPLE WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER¿S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS TROPI ES RESULTS FROM FOUR PATIENT SAMPLES PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 TROPI ES=5.61, 0.069 VS. EXPECTED <0.034 NG/ML PATIENT 2 TROPI ES=0.967 VS. EXPECTED 0.025 NG/ML PATIENT 3 TROPI ES=0.071 VS. EXPECTED < 0.012 NG/ML PATIENT 4 TROPI ES=0.079 VS. EXPECTED 0.014 NG/ML BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULTS FOR PATIENTS 1-3 WERE REPORTED FROM THE LABORATORY, HOWEVER, THE FIRST PATIENT RESULT WAS QUESTIONED BY THE PHYSICIAN AND CORRECTED REPORTS WERE LATER ISSUED FROM THE LABORATORY BASED ON REPEAT TESTING OF THE SAMPLES. PATIENT 4 WAS NOT REPORTED FROM THE LABORATORY. 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. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497666 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 1520

    Patients

    Seq Age Sex Outcome Treatment
    1