BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 17343180 · Received July 18, 2023

    Report

    Report Number
    3007111389-2023-00119
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 18, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    10758750006267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 FROM SEVERAL PATIENT SAMPLES WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE CUSTOMER DID NOT PERFORM ANY PRECISION TESTING ON THE INSTRUMENT, SO NO ASSESSMENT OF THE INSTRUMENT PERFORMANCE AT THE TIME OF THE EVENTS WAS MADE. THEREFORE, AN INSTRUMENT ISSUE COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE CUSTOMER USES A NON-VITROS BECKMAN SYSTEM AT AN ALTERNATIVE SITE TO RETEST THE VITROS IPTH SAMPLES. THE TIME DIFFERENCE BETWEEN THE TWO SITES IS APPROXIMATELY 9 HOURS AND THE SAMPLES ARE FROZEN BEFORE SHIPPING. THE VITROS IPTH IS LABILE AND SUSCEPTIBLE TO FRAGMENTATION. CORRECT HANDLING OF PATIENT SAMPLES IS NECESSARY TO ENSURE THAT THE PTH MOLECULE REMAINS INTACT. THE DEGREE OF FRAGMENTATION WILL DEPEND ON BOTH TIME AND TEMPERATURE OF STORAGE. THEREFORE, IT IS POSSIBLE THAT IMPROPER SAMPLE HANDLING BETWEEN TESTING EVENTS CONTRIBUTED TO THE HIGHER-THAN-EXPECTED PATIENT SAMPLE RESULTS, HOWEVER, THIS CANNOT BE CONFIRMED. IN ADDITION, THE CUSTOMER IS NOT FOLLOWING THE MANUFACTURER¿S RECOMMENDED SAMPLE HANDLING PROTOCOL; THEREFORE, INCORRECT PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS IPTH REAGENT LOT 1776.

    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 FROM SEVERAL PATIENT SAMPLES WHEN TESTED ON A VITROS 5600 INTEGRATED SYSTEM. VITROS IPTH LOT 1776, PATIENT 1 RESULT OF 84.51 PG/ML VERSUS THE EXPECTED NON-VITROS BECKMAN RESULT OF 40 PG/ML AND 59.6 PG/ML. VITROS IPTH LOT 1776, PATIENT 2 RESULT OF 227.9 PG/ML VERSUS THE EXPECTED NON-VITROS BECKMAN RESULT OF 148.2 PG/ML VITROS IPTH LOT 1776, PATIENT 3 RESULT OF 174.5 PG/ML VERSUS THE EXPECTED NON-VITROS BECKMAN RESULT OF 117.5 PG/ML VITROS IPTH LOT 1776, PATIENT 5 RESULT OF 158.3 PG/ML VERSUS THE EXPECTED NON-VITROS BECKMAN RESULT OF 103.4 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 RESULTS WERE NOT REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. 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
    141989 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS, INC. 6802892 1776 10758750006267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown