BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 16387333 · Received February 16, 2023

    Report

    Report Number
    3007111389-2023-00019
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    September 27, 2022
    Report Date
    February 16, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    10758750006267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES, BIORAD QC FLUIDS AND NUMEROUS PATIENT SAMPLES WERE TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH (IPTH) REAGENTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. A DEFINITIVE ASSIGNABLE CAUSE FOR THE HIGHER THAN EXPECTED VITROS IPTH RESULTS COULD NOT BE DETERMINED. WHEN THE CUSTOMER PROCESSED THE CAP PROFICIENCY SAMPLES IN (B)(6) 2022 USING REAGENT LOT 1550, ORTHO HAD BECOME AWARE OF AN ISSUE WITH OTHER REAGENT LOTS THAT WOULD PRODUCE RESULTS THAT WOULD BE LOWER THAN EXPECTED. IT IS POSSIBLE THAT THE MEAN RESULT FOR THE CAP PROFICIENCY SAMPLES WAS IMPACTED BY THE USE OF THESE LOWER RESULTING LOTS, MAKING THE CUSTOMERS CAP PROFICIENCY SAMPLE RESULTS APPEAR SLIGHTLY HIGHER WHEN COMPARED BY RESULTS POSSIBLY OBTAINED ON THOSE LOWER RESULTING LOTS POSSIBLY USED BY OTHER CUSTOMERS. BASED ON HISTORICAL QC RESULTS PROVIDED FOR VITROS IPTH REAGENT LOTS 1605 AND 1700, A VITROS IPTH PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. ADDITIONALLY, THERE IS ALSO NO INDICATION OF AN INSTRUMENT MALFUNCTION AND UNEXPECTED INSTRUMENT PERFORMANCE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS A DIAGNOSTIC WITHIN-RUN PRECISION TEST TO ASSESS INSTRUMENT PERFORMANCE PERFORMED IN JANUARY 2023 WAS WITHIN ORTHO GUIDELINES. SAMPLE HANDLING, TRANSPORTATION AND STORAGE BETWEEN PATIENT SAMPLE TESTING EVENTS BETWEEN THE CUSTOMER SITE AND THE SISTER SITE CANNOT BE RULED OUT TO CONTRIBUTING TO THE DISCORDANT PATIENT SAMPLE RESULTS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH THE VITROS IPTH REAGENT LOTS IN THIS INVESTIGATION.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY SAMPLES, BIORAD QC FLUIDS AND NUMEROUS PATIENT SAMPLES WERE TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH (IPTH) REAGENTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. VITROS IPTH LOT 1550 CAP ING-04 RESULT OF 27.7 PG/ML VS THE EXPECTED RESULT OF 20.68 PG/ML CAP ING-05 RESULT OF 218.4 PG/ML VS THE EXPECTED RESULT OF 160.12 PG/ML CAP ING-06 RESULT OF 603.7 PG/ML VS THE EXPECTED RESULT OF 438.49 PG/ML VITROS IPTH LOT 1605 BIORAD LEVEL 1 LOT 64950 RESULTS OF 43.71 AND 55.61 PG/ML VS THE EXPECTED RESULT OF 28.48 PG/ML BIORAD LEVEL 3 LOT 64950 RESULTS OF 1062.5 PG/ML VS THE EXPECTED RESULT OF 547.2 PG/ML PATIENT 1 RESULT OF 59.1 PG/ML VS THE EXPECTED RESULT OF 33.9 PG/ML PATIENT 2 RESULT OF 122.3 PG/ML VS THE EXPECTED RESULT OF 77.5 PG/ML PATIENT 3 RESULT OF 63.4 PG/ML VS THE EXPECTED RESULT OF 35.3 PG/ML PATIENT 4 RESULT OF 126.2 PG/ML VS THE EXPECTED RESULT OF 81.9 PG/ML PATIENT 5 RESULT OF 52.5 PG/ML VS THE EXPECTED RESULT OF 32.2 PG/ML VITROS IPTH LOT 1700 PATIENT 7 RESULT OF 105.59 AND 104.44 PG/ML VS THE EXPECTED RESULT OF 79.7 PG/ML PATIENT 8 RESULT OF 96.35 AND 98.36 PG/ML VS THE EXPECTED RESULT OF 72.3 PG/ML PATIENT 10 RESULT OF 93.13 AND 95.42 PG/ML VS THE EXPECTED RESULT OF 68.9 PG/ML PATIENT 11 RESULT OF 131.25 AND 134.10 PG/ML VS THE EXPECTED RESULT OF 98.7 PG/ML PATIENT 12 RESULT OF 35.0 AND 35.7 PG/ML VS THE EXPECTED RESULT OF 26.9 PG/ML PATIENT 13 RESULT OF 64.4 AND 64.4 PG/ML VS THE EXPECTED RESULT OF 41.2 PG/ML PATIENT 14 RESULT OF 29.9 AND 29.6 PG/ML VS THE EXPECTED RESULT OF 16.8 PG/ML PATIENT 16 RESULT OF 109.5 AND 105.9 PG/ML VS THE EXPECTED RESULT OF 72.1 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS IPTH CAP PROFICIENCY SAMPLE RESULTS WERE REPORTED TO THE PROFICIENCY PROVIDER. THE HIGHER THAN EXPECTED VITROS IPTH PATIENT SAMPLE RESULTS AND THE BIORAD QC FLUIDS WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF HARM. THIS REPORT IS NUMBER ONE OF SIX MDR¿S FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680479 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS, INC. 6802892 1550 10758750006267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown