BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 7981776 · Received October 18, 2018

    Report

    Report Number
    3007111389-2018-00159
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 24, 2018
    Report Date
    October 18, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO IPTH RESULTS ACQUIRED FROM ANOTHER SITE USING ANOTHER VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS IPTH REAGENT PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. THERE WAS NO INDICATION OF AN INSTRUMENT MALFUNCTION AS PRECISION TESTING PERFORMED ON THE INSTRUMENT WAS WITHIN ORTHO GUIDELINES. THEREFORE, IT DID NOT LIKELY CONTRIBUTE TO THE EVENT. IN ADDITION, SAMPLE HANDING CANNOT BE RULED OUT AS A CAUSE AS THE HANDLING, STORAGE AND AGE OF THE SAMPLES WERE UNKNOWN. MOREOVER, THE SAMPLES WERE NOT TESTED CONCURRENTLY. INTACT PTH IS LABILE AND SUSCEPTIBLE TO FRAGMENTATION AND 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 OF THE SAMPLES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE USING A VITROS 5600 INTEGRATED SYSTEM WHEN COMPARED TO IPTH RESULTS ACQUIRED FROM ANOTHER SITE USING A VITROS METHOD. PATIENT SAMPLE 7 RESULT OF 87.3 PG/ML VS. THE EXPECTED RESULT OF 125.7 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS IPTH RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823275 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 0971

    Patients

    Seq Age Sex Outcome Treatment
    1