BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 7834697 · Received August 30, 2018

    Report

    Report Number
    1319808-2018-00024
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 2, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OUR PRELIMINARY INVESTIGATION DETERMINED THAT UNDETECTED VARIABILITY IN THE RELEASE PROCESS CAUSED A NEGATIVE BIAS. WE HAVE IMPLEMENTED INTERIM CORRECTIVE ACTIONS TO HELP PREVENT FUTURE OCCURRENCES. THE FDA¿S NEW YORK DISTRICT OFFICE WAS NOTIFIED OF THIS ISSUE ON (B)(6) 2018. PLEASE REFER TO REPORT #1319808-12/12/2018-001-C.

    Description of Event or Problem · 0

    THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS VALP RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED AS PART OF A VALP LOT TO LOT CORRELATION USING A VITROS 5600 INTEGRATED SYSTEM. THE DEFINITIVE ASSIGNABLE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. HOWEVER, A POSSIBLE CONTRIBUTOR TO THE EVENT WAS SUSPECTED TO BE CALIBRATION TO CALIBRATION VARIABILITY. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH EITHER VALP LOT (2511-25-6393 AND 2511-26-6711) BASED ON QC PERFORMANCE; HOWEVER, THE ACCURACY OF RESULTS OBTAINED USING VALP LOT 2511-25-6393 WAS LOWER THAN THE ACCURACY OF RESULTS OBTAINED USING VALP LOT 2511-26-6711 AS SHOWN WITH THE PATIENT CORRELATION RESULTS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMIC ISSUE WITH EITHER OF THE VITROS VALP REAGENT LOTS. AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CAUSE OF THE EVENT AS THE TWO VITROS 5600 SYSTEMS GENERATED REPRODUCIBLE RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A LOWER THAN EXPECTED VITROS VALP RESULT (66.41 UG/ML VERSUS EXPECTED 83.17, 83.53, 86.31 UG/ML) FROM A PATIENT SAMPLE PROCESSED USING THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE PATIENT SAMPLE RESULT IN QUESTION WAS OBTAINED AS PART OF VALP LOT TO LOT CORRELATION STUDY AND THEREFORE, NO PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674708 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-6393

    Patients

    Seq Age Sex Outcome Treatment
    1