BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 17809108 · Received September 25, 2023

    Report

    Report Number
    3007111389-2023-00170
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 21, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    10758750006267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A DISCORDANT, LOWER-THAN-EXPECTED RESULT FROM VITROS INTACT PTH (IPTH) REAGENT LOT 1711, WAS OBTAINED WHEN PROCESSING A NON-VITROS MAS OMNI-IMMUNE QUALITY CONTROL (QC) FLUID, LOT OIM2411 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE CAUSE OF THE LOWER-THAN-EXPECTED VITROS IPTH QC SAMPLE RESULT COULD NOT BE DETERMINED. SAMPLE HANDLING AND STORAGE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT AS IT WAS DETERMINED THAT THE CUSTOMER IS NOT FOLLOWING THE MANUFACTURERS RECOMMENDATION FOR HANDLING AND STORAGE OF THE MAS OMNI-IMMUNE QC FLUIDS. AN INSTRUMENT RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT, HOWEVER, AS THE NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED AT THE TIME OF THE EVENTS, AN INSTRUMENT RELATED ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENTS. A HISTORICAL REVIEW OF VITROS IPTH LOT 1711 FOLLOWING THE FIRST EVENT ON (B)(6) 2023 INDICATES THERE HAS BEEN IMPRECISION AND ACCURACY ISSUES. THEREFORE, A PERFORMANCE ISSUE WITH IPTH REAGENT LOT 1711 CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS IPTH REAGENT LOT 1711.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, LOWER-THAN-EXPECTED RESULT FROM VITROS INTACT PTH (IPTH) REAGENT LOT 1711, WHEN PROCESSING A SINGLE LEVEL OF NON-VITROS MAS OMNI-IMMUNE QUALITY CONTROL (QC) FLUID, LOT OIM2411 ON A VITROS XT 7600 INTEGRATED SYSTEM. MAS LOT OIM 2411 LEVEL 3 RESULT OF 627.22 PG/ML VS. THE EXPECTED VITROS ASSIGNED MAS PI MEAN RESULT OF 1340.25 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 OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE. THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO REOCCUR UNDETECTED. ORTHO IS NOT AWARE OF ANY REPORTED 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
    1873150 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS, INC. 6802892 1711 10758750006267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown