BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 16994187 · Received May 24, 2023

    Report

    Report Number
    3007111389-2023-00080
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    April 8, 2023
    Report Date
    May 24, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    CEW
    UDI-DI
    10758750006267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN A NON-VITROS THERMOFISHER MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUID WAS TESTED ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. A DEFINITIVE ASSIGNABLE CAUSE FOR THE DISCORDANT LOWER THAN EXPECTED VITROS IPTH RESULTS COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. BASED ON NO HISTORICAL QUALITY CONTROL RESULTS PERFORMED FOR VITROS IPTH LOT 1750, A REAGENT ISSUE CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTOR TO THE EVENT AS THE CUSTOMER DOES NOT RUN DAILY QUALITY CONTROL. THE CUSTOMER GAVE NO INDICATION OF ANY INSTRUMENT MALFUNCTION, AND AN UNEXPECTED INSTRUMENT PERFORMANCE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, INSTRUMENT J1 RESULTS WERE SIMILAR TO INSTRUMENT J2 RESULTS, THEREFORE, WHILE AN INSTRUMENT PERFORMANCE ISSUE CANNOT BE ENTIRELY RULED OUT, IT IS AN UNLIKELY CONTRIBUTOR TO THE EVENT. THE CUSTOMER DID NOT PERFORM ANY PRECISION TESTING ON THE INSTRUMENTS AT THE TIME OF THE EVENTS; SO, NO ASSESSMENT OF THE INSTRUMENT PERFORMANCE AT THE TIME OF THE EVENTS WAS MADE. THEREFORE, IT CANNOT BE CONFIRMED IF THE INSTRUMENTS WERE PERFORMING AS INTENDED AND UNEXPECTED INSTRUMENT PERFORMANCE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENTS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS IPTH REAGENT LOT 1750.

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN A NON-VITROS THERMOFISHER MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUID WAS TESTED ON TWO VITROS XT 7600 INTEGRATED SYSTEMS. VITROS IPTH LOT 1750 RESULTS: MAS LOT OIM 24111A LEVEL 1 RESULTS OF 12.92 AND 16.56 PG/ML VERSUS THE EXPECTED RESULT (BASELINE MEAN) OF 25.4 PG/ML MAS LOT OIM 24111A LEVEL 2 RESULTS OF 45.57 AND 46 PG/ML VERSUS THE EXPECTED RESULT (BASELINE MEAN) OF 76.9 PG/ML MAS LOT OIM 24111A LEVEL 3 RESULTS OF 824 AND 908 PG/ML VERSUS THE EXPECTED RESULT (BASELINE MEAN) OF 1340 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS IPTH RESULTS OBTAINED WERE FROM NON-PATIENT FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ORTHO IS NOT AWARE OF ANY REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S 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 NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT 601883.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370773 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITRO DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS, INC. 6802892 1750 10758750006267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown