BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    MDR report key: 15977114 · Received December 14, 2022

    Report

    Report Number
    3007111389-2022-00668
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 16, 2022
    Report Date
    December 14, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CEW
    UDI-DI
    10758750006267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 NON-VITROS MAS QUALITY CONTROL (QC) FLUIDS WERE PROCESSED USING VITROS IPTH REAGENT LOT: 1660 ON A VITROS XT7600 INTEGRATED SYSTEM. ORTHO¿S INVESTIGATION HAS IDENTIFIED THE ROOT CAUSE OF THIS ISSUE STEMS FROM A RAW MATERIAL USED IN THE AFFECTED LOTS. ON (B)(6) 2022, A COMMUNICATION (CL2022-275 POTENTIAL FOR NEGATIVE BIAS WHEN USING VITROS® IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK) WAS SENT TO ALL CUSTOMERS WHO HAVE BEEN SHIPPED VITROS IPTH REAGENT PACK WITHIN THE PREVIOUS 12 MONTHS. THE COMMUNICATION INFORMED CUSTOMERS THAT WHEN USING THE AFFECTED IPTH LOTS LISTED, CUSTOMERS MAY EXPERIENCE LOWER THAN EXPECTED RESULTS. WHEN PROCESSING PATIENT SAMPLES AN AVERAGE NEGATIVE BIAS OF APPROXIMATELY -12% MAY BE OBSERVED. IN ADDITION, A VARIABLE NEGATIVE SHIFT IN PERFORMANCE WAS ALSO CONFIRMED USING BIORAD LIQUICHEK/LYPHOCHEK SPECIALTY IMMUNOASSAY CONTROLS AND THERMOFISHER SCIENTIFIC MAS OMNI IMMUNE IMMUNOASSAY CONTROLS WHEN COMPARED TO THEIR PUBLISHED ASSIGNED VALUES. ORTHO HAS ASSIGNED NEW MEAN AND SD VALUES FOR AVAILABLE BIORAD AND THERMOFISHER CONTROL LOTS FOR USE SPECIFICALLY WITH THE AFFECTED LOTS LISTED IN THE COMMUNICATION. VITROS IMMUNODIAGNOSTIC PRODUCTS IPTH CONTROLS DO NOT DETECT THIS BIAS, THEREFORE NO PERFORMANCE SHIFTS OF THE CONTROLS WERE OBSERVED. WITHIN RUN PRECISION TESTING WAS NOT PROCESSED ON THE VITROS 5600 SYSTEM AROUND THE TIME OF THE EVENT, HOWEVER THE CUSTOMER GAVE NO INDICATING THAT THE INSTRUMENT WAS MALFUNCTIONING OR THAT ANY OTHER ASSAYS WERE AFFECTED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS INTACT PTH (IPTH) RESULTS WERE OBTAINED WHEN NON-VITROS MAS QUALITY CONTROL (QC) FLUIDS WERE PROCESSED USING VITROS IPTH REAGENT LOT :1660 ON A VITROS XT7600 INTEGRATED SYSTEM. MAS LOT: OIM 23021 LEVEL 1 RESULTS OF 12.00, 13.57 13.58, 14.19, 13.14 AND 9.45 PG/ML VERSUS THE EXPECTED RESULT (BASELINE MEAN) OF 20.3 PG/L MAS LOT: OIM 23023 LEVEL 3 RESULTS OF 653.542, 639.759, 626.061, 516.188, 646.077, 615.142, 651.906, 603.425, 465.545, 399.481 AND 627.97, 620.35 AND 654.39 PG/ML VERSUS THE EXPECTED RESULT (BASELINE MEAN) OF 936 PG/ML THE LOWER-THAN-EXPECTED VITROS IPTH RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING NON-PATIENT FLUIDS. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FOUR OF FOUR MDR¿S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456933 VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK IN-VITROS DIAGNOSTICS CEW ORTHO-CLINICAL DIAGNOSTICS 6802892 1660 10758750006267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown