BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    MDR report key: 18132446 · Received November 14, 2023

    Report

    Report Number
    0001319809-2023-00157
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 13, 2023
    Report Date
    June 24, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED THE UDI IN FIELD D4 TO INCLUDE DEVICE IDENTIFIER (DI) AND PRODUCTION IDENTIFIER (PI) PER EMAIL REQUEST FROM FDA ON (B)(6) 2024.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) AND PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) LOT OCR2406 USING VITROS DGXN SLIDE LOT 1932-0268-4412 AND VITROS PHBR SLIDE LOT 2509-0098-9932, TESTED ON A VITROS XT7600 SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. AN INSTRUMENT RELATED ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT AS A DIAGNOSTIC VITROS CRBM WITHIN-RUN PRECISION TEST WAS ACCEPTABLE, INDICATING THE VITROS XT7600 INTEGRATED SYSTEM WAS PERFORMING AS INTENDED. A VITROS DGXN AND PHBR SLIDE ISSUE COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. ACCEPTABLE VITROS PHBR PERFORMANCE WAS OBTAINED AFTER AN ADDITIONAL CALIBRATION EVENT, HOWEVER, THE CALIBRATION RESPONSES AND PARAMETERS FROM WHICH THE LOWER THAN EXPECTED RESULTS WERE OBTAINED APPEARED TYPICAL TO EXPECTED RESPONSES AND PARAMETERS. ACCEPTABLE VITROS DGXN PERFORMANCE WAS OBTAINED AFTER AN ALTERNATE VITROS DGXN SLIDE LOT, 1932-0268-5736, WAS PUT INTO USE. THEREFORE A PERFORMANCE ISSUE WITH VITROS DGXN SLIDE LOT 1932-0268-4412 CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS DGXN SLIDE LOT 1932-0268-4412 OR VITROS PHBR SLIDE LOT 2509-0098-9932.

    Description of Event or Problem · 0

    THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) AND PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) LOT OCR2406 USING VITROS DGXN SLIDE LOT 1932-0268-4412 AND VITROS PHBR SLIDE LOT 2509-0098-9932, TESTED ON A VITROS XT7600 SYSTEM. MAS LEVEL 3 DGXN RESULTS OF 1.49, 1.03, 1.00, 1.39, 1.38, 1.04, 1.22, 1.26, 0.96, 1.10, 1.37, 1.37, 1.48, 1.28, 1.23, 1.16, 1.04, 1.48, 1.36, 1.48, 1.05, 1.14 AND 1.40 NG/ML VS. AN EXPECTED RESULT OF 2.02 NG/ML. MAS LEVEL 3 PHBR RESULTS OF 44.2, 44.8, 43.9 AND 44.9 UG/ML VS. AN EXPECTED RESULT OF 56.88 UG/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 AFFECTED QUALITY CONTROL SAMPLE WAS A NON-PATIENT QUALITY CONTROL SAMPLE. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED AND THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER TWENTY SIX OF TWENTY SEVEN MDR¿S FOR THIS EVENT. TWENTY SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWENTY SEVEN DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027209 VITROS CHEMISTRY PRODUCTS PHBR SLIDES IN-VITRO DIAGNOSTICS DLZ ORTHO-CLINICAL DIAGNOSTICS, INC. 2509-0098-9932

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown