BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 19932953 · Received August 7, 2024

    Report

    Report Number
    3007111389-2024-00153
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 3, 2024
    Report Date
    August 7, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    10758750006267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN SAMPLES FROM MULTIPLE PATIENTS WERE TESTED USING VITROS IPTH LOT 1980 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO ROCHE PTH RESULTS FOR THE SAME PATIENT SAMPLES. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. HISTORICAL QC RESULTS FROM BIORAD QC TESTING INDICATE ACCEPTABLE VITROS IPTH LOT 1980 PERFORMANCE. ADDITIONALLY, VITROS IPTH LOT 1980 PERFORMANCE WAS DEEMED ACCEPTABLE FROM VITROS IPTH CONTROL TESTING AND ONGOING TRACKING AND TRENDING DID NOT IDENTIFY ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS IPTH LOT 1980. AN INSTRUMENT RELATED ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT, HOWEVER, AS THERE WAS NO DIAGNOSTIC PRECISION TESTING CONDUCTED TO VERIFY THE PERFORMANCE OF THE VITROS XT7600 INTEGRATED SYSTEM, AN INSTRUMENT RELATED ISSUE CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTOR TO THE EVENT. IMPROPER STORAGE AND HANDLING OF THE PATIENT SAMPLES CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. ROCHE PTH TESTING OCCURRED UP TO TWO DAYS FOLLOWING VITROS IPTH TESTING FOR THE PATIENTS AND AS IPTH IS SUSCEPTIBLE TO FRAGMENTATION, IT IS POSSIBLE THE TIME BETWEEN TESTING EVENTS CONTRIBUTED TO THE DISCORDANCE OBSERVED BETWEEN THE VITROS IPTH AND ROCHE PTH METHODS AND THAT THE HIGHER VITROS IPTH RESULTS FOR THE PATIENTS WERE ACCURATE, HOWEVER, THIS COULD NOT BE CONFIRMED. METHOD TO METHOD DIFFERENCES BETWEEN THE VITROS IPTH AND ROCHE PTH METHODS CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT AS THE METHODS FOR IPTH TESTING ARE NOT STANDARDIZED, THEREFORE NUMERICAL VARIATION CAN BE SEEN BETWEEN METHODS. ORTHO ISSUED CUSTOMER LETTERS (CL2016-196, 05 OCTOBER 2016 AND CL2016-220, 24 NOVEMBER 2016) INDICATING THAT THE RESULTS OBSERVED FOR PATIENT SAMPLES ON THE VITROS IPTH ASSAY WERE HIGH WHEN COMPARED TO ALTERNATE METHODS AND THAT AN ATYPICAL NUMBER OF SAMPLES WERE PREDICTING ABOVE THE REFERENCE INTERVAL.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN SAMPLES FROM MULTIPLE PATIENTS WERE TESTED USING VITROS IPTH LOT 1980 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO ROCHE PTH RESULTS FOR THE SAME PATIENT SAMPLES. PATIENT 1, VITROS IPTH RESULT OF 100.57 PG/ML VERSUS THE ROCHE PTH RESULT OF 65.9 PG/ML PATIENT 2, VITROS IPTH RESULTS OF 96.00, 74.44 AND 86.04. PG/ML VERSUS THE ROCHE PTH RESULT OF 63.2 PG/ML PATIENT 3, VITROS IPTH RESULT OF 129.79. PG/ML VERSUS THE ROCHE PTH RESULT OF 79.9 PG/ML PATIENT 4, VITROS IPTH RESULT OF 135.00. PG/ML VERSUS THE ROCHE PTH RESULT OF 93.2 PG/ML PATIENT 5, VITROS IPTH RESULT OF 109.86. PG/ML VERSUS THE ROCHE PTH RESULT OF 69.5 PG/ML PATIENT 6, VITROS IPTH RESULT OF 80.48. PG/ML VERSUS THE ROCHE PTH RESULT OF 52.7 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 RESULTS WERE REPORTED FROM THE LABORATORY. HOWEVER, NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULTS AND CORRECTED REPORTS DOCUMENTING THE ROCHE RESULTS WERE LATER ISSUED. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS 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 (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 606932.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518294 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS, INC. 1980 10758750006267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown