BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 8048155 · Received November 7, 2018

    Report

    Report Number
    1319808-2018-00045
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 4, 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 DETERMINED THAT LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM PATIENT SAMPLES PROCESSED AS PART OF A VALP LOT TO LOT CORRELATION USING A VITROS 4600 CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSES FOR THIS EVENT ARE VALP LOT TO LOT VARIABILITY AND CALIBRATION TO CALIBRATION VARIABILITY. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE VITROS VALP LOTS (2511-25-6067, 2511-26-6711 AND 2511-26-6892) USED IN THE PATIENT CORRELATION BASED ON QUALITY CONTROL (QC) PERFORMANCE; HOWEVER, THE VITROS VALP LOT 2511-25-6067 ACCURACY WAS LOWER THAN BOTH VALP LOTS 2511-26-6711 AND 2511-26-6892 AS SHOWN WITH THE PATIENT CORRELATION RESULTS. VALP GEN 26 PERFORMANCE WAS SET TO THE REFERENCE METHOD AT RELEASE AND RESULTED IN A SHIFT HIGH OVER GEN 25 PERFORMANCE. IT WAS CONFIRMED BY ORTHO THAT BOTH VITROS VALP GEN 25 AND GEN 26 LOTS HAVE PERFORMED WITHIN ORTHO RELEASE GUIDELINES. THE PERFORMANCE OF VITROS CONTROLS WERE ACCEPTABLE AND ORTHO RELEASE DATA WAS WITHIN SPECIFICATIONS. FURTHERMORE, THE CUSTOMER INDICATED THAT ANY SHIFT IN PATIENT DATA SEEN WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT AT THE TIME. ADDITIONALLY, BECAUSE PRE-ANALYTICAL SPECIMEN STORAGE AND HANDLING INFORMATION WERE NOT PROVIDED, PRE-ANALYTICAL SAMPLE HANDLING AND STORAGE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULTS FROM PATIENT SAMPLES USING A VITROS 4600 CHEMISTRY SYSTEM IN COMBINATION WITH VITROS VALP REAGENT. SAMPLE 1 = 35.7 VERSUS EXPECTED 52.3 MG/L. SAMPLE 2 = 23.4 VERSUS EXPECTED 34.5 MG/L. SAMPLE 3 = 79.5 VERSUS EXPECTED 104.8 MG/L. SAMPLE 4 = 91 VERSUS EXPECTED 118 MG/L . SAMPLE 6 = 102.8 VERSUS EXPECTED 128.7 MG/L . BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. ORTHO HAS NOT BEEN 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 NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888353 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-6067

    Patients

    Seq Age Sex Outcome Treatment
    1