BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

    MDR report key: 20409824 · Received October 9, 2024

    Report

    Report Number
    3007111389-2024-00194
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 12, 2024
    Report Date
    October 9, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    NBC
    UDI-DI
    10758750032822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUDES THAT LOWER THAN EXPECTED VITROS NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED WHEN PROCESSING A SINGLE LEVEL OF NON-VITROS QUALITY CONTROL FLUID ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED RESULTS COULD NOT BE DETERMINED. A PERFORMANCE ISSUE WITH THE VITROS XT 7600 INTEGRATED SYSTEM COULD NOT BE RULED AS CONTRIBUTING TO THE EVENT AS MULTIPLE WITHIN-RUN NT-PROBNP2 PRECISION TESTS PERFORMED USING BIORAD AND MAS CONTROL FLUIDS WERE OUTSIDE OF ACCEPTABLE GUIDELINES. HOWEVER, AS NO DIAGNOSTIC VITROS TSH WITHIN-RUN PRECISION TESTING, USED BY ORTHO TO ASSESS THE PERFORMANCE OF THE VITROS XT 7600 INTEGRATED SYSTEM, WAS PROCESSED, AN INSTRUMENT RELATED ISSUE COULD NOT BE CONFIRMED. A PERFORMANCE ISSUE WITH VITROS NBNP2 LOT 0350 COULD NOT BE RULED OUT AS A REVIEW OF QUALITY CONTROL RESULTS FOR VITROS NBNP2 LOT 0350 WERE IMPRECISE. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS NBNP2 LOT 0350. A PERFORMANCE ISSUE WITH THE NON-VITROS BIORAD CONTROLS CANNOT BE RULED OUT AS ACCEPTABLE PERFORMANCE WAS OBTAINED FROM VITROS NBNP2 CONTROLS, HOWEVER, AN INADEQUATE NUMBER OF DATA POINTS OBTAINED FROM VITROS NBNP2 CONTROLS TO FULLY ASSESS PERFORMANCE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED WHEN PROCESSING A SINGLE LEVEL OF NON-VITROS QUALITY CONTROL FLUID ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD CARDIAC MARKERS PLUS LT LOT 1003110 VITROS NBNP2 RESULTS 102.7, 101.4, 98.6, 99.9, 104.9, 99.5 AND 96.3 PG/ML VERSUS THE PEER MEAN 142.9 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 NBNP2 RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. NO ALLEGATION OF PATIENT HARM WAS REPORTED AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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 NUMBERS (B)(4), (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737139 VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK IN-VITRO DIAGNOSTICS NBC ORTHO-CLINICAL DIAGNOSTICS, INC. 0350 10758750032822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown