BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT

    MDR report key: 4814555 · Received June 3, 2015

    Report

    Report Number
    3007111389-2015-00137
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 5, 2015
    Report Date
    June 3, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT REPRODUCIBLE, LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, AN UNKNOWN SAMPLE INTERFERENT OR METHOD TO METHOD DIFFERENCES CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THERE WAS NO EVIDENCE THAT THE VITROS ECIQ ANALYZER HAD MALFUNCTIONED. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED REPRODUCIBLE, LOWER THAN EXPECTED, VITROS TSH RESULTS OBTAINED FROM MULTIPLE PATIENT SAMPLES PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM, WHEN COMPARED TO THE EXPECTED RESULTS OBTAINED FROM A NON-VITROS SYSTEM. (B)(6). BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE PATIENT 1 (B)(6) WERE REPORTED OUTSIDE THE LABORATORY; HOWEVER, A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE WAS NO ALLEGATION OF INAPPROPRIATE ACTION TAKEN RESULTING IN PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FOUR MDRS FOR THIS EVENT. FOUR 3500 FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359372 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS 4720

    Patients

    Seq Age Sex Outcome Treatment
    1