BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK

    MDR report key: 11731413 · Received April 27, 2021

    Report

    Report Number
    3007111389-2021-00061
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 27, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED TSH RESULT WAS OBTAINED FROM A VITROS FTC QC FLUID WHEN TESTED USING VITROS TSH REAGENT LOT 6385 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE WAS NOT ESTABLISHED. BASED ON HISTORICAL QC RESULTS, A VITROS TSH REAGENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT. ADDITIONALLY, REPEAT VITROS TSH RESULTS FROM THE VITROS FTC C3 FLUID WERE ACCEPTABLE ON THE DATE OF THE EVENT. POST-EVENT VITROS TSH RESULTS FROM VITROS FTC FLUID TESTING WERE WITHIN ACCEPTABLE GUIDELINES. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS TSH REAGENT LOT 6385. A POTENTIAL CONTAMINATION ISSUE WITH VITROS FTC C3 VIAL IN USE IS A POSSIBLE CONTRIBUTOR TO THE EVENT. REPEAT RESULTS FROM A FRESH VIAL OF THE VITROS FTC C3 WERE WITHIN ACCEPTABLE GUIDELINES. INCORRECT QC FLUID HANDLING IS AN UNLIKELY CONTRIBUTOR TO THE EVENT AS THE CUSTOMER INDICATED THEY FOLLOW THE PROPER PROTOCOL FOR QC FLUID HANDLING. ADDITIONALLY, A TRANSIENT INSTRUMENT ISSUE ON THE DATE OF THE EVENT CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. DIAGNOSTIC PRECISION TESTING ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WAS WITHIN ACCEPTABLE GUIDELINES FOLLOWING THE EVENT. HOWEVER, NO PRECISION TESTING WAS PERFORMED AROUND THE TIME OF THE EVENT, THEREFORE AN INSTRUMENT ISSUE IS A POTENTIAL CONTRIBUTOR. EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(4).

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED TSH RESULT WAS OBTAINED FROM A VITROS FREE THYROID CONTROL (FTC) QC FLUID WHEN TESTED USING VITROS TSH REAGENT LOT 6385 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. VITROS FTC CONTROL 3 (C3) FLUID LOT 0660 = 24.087 MIU/L VERSUS THE PACKAGE INSERT MEAN RESULT OF 18.5 MIU/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS TSH RESULT WAS OBTAINED FROM A NON-PATIENT SAMPLE. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627176 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK IN-VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS 6385

    Patients

    Seq Age Sex Outcome Treatment
    1