BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK

    MDR report key: 17769707 · Received September 18, 2023

    Report

    Report Number
    3007111389-2023-00161
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 22, 2023
    Report Date
    September 18, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JLW
    UDI-DI
    10758750000227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A NON-VITROS MAS QUALITY CONTROL FLUID USING VITROS TSH LOT 7090 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED VITROS TSH RESULTS COULD NOT BE DETERMINED. A VITROS TSH PERFORMANCE ISSUE CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR TO THE EVENT. HISTORICAL TSH QUALITY CONTROL RESULTS INDICATE SOME INACCURACY AND IMPRECISION. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS TSH REAGENT LOT 7090. THE CUSTOMER IS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURER RECOMMENDATIONS FOR SAMPLE HANDLING, THERE PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. A SAMPLE SPECIFIC ISSUE THAT AFFECTS THE VITROS TSH METHOD AND NOT THE NON-VITROS METHOD CANNOT RULED OUT AS A CAUSE FOR THE LOWER THAN EXPECTED VITROS TSH PATIENT RESULTS OBTAINED. PRECISION TESTING OF THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMED, THEREFORE AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR TO THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED LOWER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A NON-VITROS MAS QUALITY CONTROL FLUID USING VITROS TSH LOT 7090 ON A VITROS 5600 INTEGRATED SYSTEM. THE PATIENT RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO TSH RESULTS OBTAINED FROM AN ALTERNATE METHOD. PATIENT TSH = 0.07, 0.08 MIU/L VERSUS EXPECTED RESULT OF 3.28 MIU/ML MAS L3 LOT OIM27033A TSH = 25.265 MIU/ML VERSUS EXPECTED RESULT OF 37.10 MIU/ML BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE LOWER THAN EXPECTED VITROS TSH PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS 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. COMPLAINT NUMBER (B)(4) / REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105481 VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT PACK IN VITRO DIAGNOSTICS JLW ORTHO-CLINICAL DIAGNOSTICS 1912997 7090 10758750000227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown