BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 7707136 · Received July 20, 2018

    Report

    Report Number
    1319808-2018-00020
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    June 13, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 12 DECEMBER 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 HAS DETERMINED THAT A HIGHER THAN EXPECTED VITROS VALP RESULT WAS OBTAINED WHEN PROCESSING A PATIENT SAMPLE DURING A PATIENT CORRELATION ON A VITROS 5600 SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS CALIBRATION TO CALIBRATION VARIABILITY. THE CUSTOMER PROCESSED A LOT TO LOT PATIENT COMPARISON AND NOTED A SHIFT LOW IN VALP RESULTS GENERATED USING THE NEW VALP REAGENT LOT. THE CUSTOMER RECALIBRATED VITROS VALP LOT 2511-25-5974 AND REPEATED THE PATIENT COMPARISON USING THE SAME VITROS 5600 SYSTEM AND AN ALTERNATE VITROS 5600 SYSTEM IN THE LABORATORY. THE RECALIBRATION OF VITROS VALP LOT 2511-25-5974 RESULTED IN ACCEPTABLE QUALITY CONTROL AND PATIENT CORRELATION RESULTS ON BOTH VITROS 5600 SYSTEMS. THIS WOULD INDICATE THAT, WHILE ACCEPTABLE, THE CALIBRATION PERFORMED ON 12 JANUARY 2018 WAS DIFFERENT ENOUGH FROM THE NEW CALIBRATION TO BE CONSIDERED SUBOPTIMAL. THE INVESTIGATION CONCLUDED THE ASSIGNABLE CAUSE WAS CALIBRATION TO CALIBRATION VARIABILITY. THERE WAS NO INDICATION THAT AN INSTRUMENT ISSUE CONTRIBUTED TO THE EVENT. IN ADDITION, A COMPLAINT REVIEW OF VALP LOT 2511-25-5974 DID NOT INDICATE A REAGENT ISSUE. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP LOT 2511-25-5974. THE MDR IS BEING SUBMITTED AFTER THE 30 DAY REPORTING DATE DUE TO A TECHNICAL ISSUE WITH ORTHO¿S MDR REPORTING SYSTEM. ORTHO WAS UNABLE TO ELECTRONICALLY SUBMIT MDRS FROM 5 JULY 2018 ¿ 19 JULY 2018.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS VALP RESULT FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 SYSTEM DURING A PATIENT CORRELATION. PATIENT 4 SAMPLE, VITROS VALP (2511-25-5974) RESULT 403 UMOL/L VERSUS THE VITROS VALP (LOT 2511-25-6393) RESULTS 332 AND 331 UMOL/L. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE MEDICAL ACTION IF NOT DETECTED. THE HIGHER THAN EXPECTED VITROS VALP RESULT WAS NOT REPORTED FROM THE LABORATORY. ORTHO WAS NOT MADE AWARE OF ANY ERRONEOUS PATIENT SAMPLE RESULTS THAT WERE OBTAINED OR REPORTED FROM THE LABORATORY. THERE WAS NO 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
    547749 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-5974

    Patients

    Seq Age Sex Outcome Treatment
    1