BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 2230364 · Received September 1, 2011

    Report

    Report Number
    3007111389-2011-00126
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS TSH QUALITY CONTROL AND PATIENT RESULTS WERE OBTAINED USING TWO VITROS 5600 INTEGRATED SYSTEMS. THERE WAS NO EVIDENCE TO SUGGEST THAT AN INSTRUMENT MALFUNCTION HAD OCCURRED. ACCEPTABLE PERFORMANCE HAS BEEN OBSERVED USING AN ALTERNATE LOT OF VITROS TSH REAGENT. HOWEVER, OCD HAS RECEIVED NO RELATED CUSTOMER COMPLAINTS FOR VITROS TSH LOT 2920. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE VITROS TSH REAGENT COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN, AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS TSH RESULTS FOR VITROS FREE THYROID QUALITY CONTROL (LEVELS 1,2,& 3) AND A SINGLE PATIENT SAMPLE RESULTS USING TWO VITROS 5600 INTEGRATED SYSTEMS. ( VITROS FREE THYROID CONTROL LEVEL 1 FLUID 0.015 MIU/L VS. 0.064 MIU/L, LEVEL 2 0.631 MIU/L VS. 1.67 MIU/L, LEVEL 3 9.71 MIU/L VS. 19.9 MIU/L). IN ADDITION, FOR A SINGLE PATIENT SAMPLE, A VALUE OF 0.043 MIU/L VS. 0.200 MIU/L WAS OBTAINED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER THAN EXPECTED VITROS TSH PATIENT RESULT WAS NO REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS 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 TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 2920

    Patients

    Seq Age Sex Outcome Treatment
    1