BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 15340230 · Received September 1, 2022

    Report

    Report Number
    1319809-2022-00063
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    May 21, 2022
    Report Date
    September 1, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED BOTH LOWER AND HIGHER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULTS OBTAINED FROM 2 DIFFERENT NON-PATIENT CAP PROFICIENCY SAMPLES, USING VITROS PHYT SLIDE LOT 2621-0180-7301, TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THIS EVENT IS USER ERROR DUE TO CONFIGURATION OF THE SIGNIFICANT DIGITS. THE CUSTOMER DID NOT PROVIDE WHAT VALUE WAS CONFIGURED FOR SIGNIFICANT DIGITS, BUT IT WAS LIKELY 1, SINCE THE VITROS PHYT RESULTS OBTAINED WERE ROUNDED TO THE NEAREST WHOLE NUMBER. IT IS UNKNOWN HOW LONG THE CONFIGURATION WAS IN PLACE. THE CUSTOMER RECONFIGURED THE SIGNIFICANT DIGITS AND VITROS PHYT RESULTS WERE NOW DISPLAYED AS EXPECTED. HISTORIC VITROS PHYT QUALITY CONTROL RESULTS USING VITROS PHYT SLIDE LOT 2621-0180-7301 WERE WITHIN EXPECTED RANGES, INDICATING VITROS PHYT SLIDE LOT 2621-0180-7301 DID NOT LIKELY CONTRIBUTED TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS PHYT SLIDE LOT 2621-0180-7301. EMAIL ADDRESS FOR CONTACT OFFICE IN ABOVE IS (B)(6).

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS PHENYTOIN (PHYT) RESULTS OBTAINED FROM 2 DIFFERENT NON-PATIENT CAP PROFICIENCY SAMPLES, USING VITROS PHYT SLIDE LOT 2621-0180-7301, TESTED ON A VITROS 5600 INTEGRATED SYSTEM. CAP PROFICIENCY SAMPLE CHM-09 VITROS PHYT RESULT OF 10.0 VERSUS EXPECTED VITROS PEER MEAN OF 14.41 UG/ML CAP PROFICIENCY SAMPLE CHM-10 VITROS PHYT RESULT OF 30.0 VERSUS EXPECTED VITROS PEER MEAN OF 23.47 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. NO VITROS PHYT PATIENT RESULTS WERE QUESTIONED, THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2806297 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTICS DIP ORTHO-CLINICAL DIAGNOSTICS 2621-0180-7301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown