BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK

    MDR report key: 4953439 · Received July 30, 2015

    Report

    Report Number
    3007111389-2015-00243
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 30, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED TSH QUALITY CONTROL RESULT WAS OBTAINED FROM A SINGLE LEVEL OF VITROS FTC L2 TESTED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN; HOWEVER, A PRE-ANALYTICAL SAMPLE RELATED ISSUE, AN UNEXPECTED REAGENT OR AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT A LOWER THAN EXPECTED TSH QUALITY CONTROL RESULT WAS OBTAINED FROM A SINGLE LEVEL OF VITROS FTC L2 TESTED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM. VITROS FTC L2 RESULT: 0.077 MIU/L VS EXPECTED 1.42 MIU/L BASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER STATED THAT VITROS TSH PATIENT SAMPLE RESULTS WERE AFFECTED; HOWEVER, NO EXAMPLES WERE PROVIDED. THEREFORE, OCD CANNOT RULE OUT OR CONFIRM THAT PATIENT SAMPLES WERE AFFECTED. THE INVESTIGATION IS UNABLE TO RULE OUT THAT PATIENT SAMPLE RESULTS COULD BE AFFECTED IF THE EVENT WERE TO RECUR AGAIN UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498656 VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTIC JLW ORTHO-CLINICAL DIAGNOSTICS 4750

    Patients

    Seq Age Sex Outcome Treatment
    1