BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 7958044 · Received October 11, 2018

    Report

    Report Number
    1319808-2018-00040
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 20, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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 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 MOST LIKELY ASSIGNABLE CAUSE IS A COMBINATION OF VITROS VALP LOT TO LOT VARIABILITY AND PRE-ANALYTICAL SAMPLE HANDLING. THE CUSTOMER INDICATED THE SPECIMENS WERE TESTED DAYS BEYOND ORIGINAL COLLECTION DATE, POURED OFF MULTIPLE TIMES, AND SUBJECTED TO MULTIPLE REFRIGERATION/AMBIENT TEMPERATURE CYCLES. THEREFORE, IT IS CONCLUDED THAT THE PRE-ANALYTICAL SAMPLE HANDLING IS A CONTRIBUTOR TO THIS EVENT. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE VITROS VALP LOTS (2511-25-6393 AND 2511-26-6711) USED IN THE PATIENT CORRELATION BASED ON QC PERFORMANCE; HOWEVER, THE VITROS VALP LOT 2511-25-6393 ACCURACY WAS LOWER THAN VALP LOT 2511-26-6711 AS SHOWN WITH THE PATIENT CORRELATION RESULTS. THE VITROS VALP LOT 2511-26-6711 PERFORMANCE WAS SET TO THE REFERENCE METHOD AND THEREFORE, THE RESULTS FROM THAT LOT WERE CONSIDERED THE EXPECTED RESULTS FOR THIS CORRELATION DATA SET. IT WAS CONFIRMED BY ORTHO THAT BOTH VITROS VALP LOTS HAVE PERFORMED WITHIN ORTHO RELEASE GUIDELINES. THERE WAS NO INDICATION OF A VITROS 5600 SYSTEM MALFUNCTION BASED ON ACCEPTABLE WITHIN RUN PRECISION RESULTS.

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VALPROIC ACID RESULTS WERE OBTAINED FROM PATIENT SAMPLES USING A VITROS 5600 INTEGRATED SYSTEM IN COMBINATION WITH VITROS VALP REAGENT. SAMPLE 1 = 56.3 VERSUS EXPECTED 71.0 UG/ML, SAMPLE 3 = 78.5 VERSUS EXPECTED 98.6 UG/ML , SAMPLE 8 = 46.0 VERSUS EXPECTED 58.5 UG/ML, SAMPLE 9 = 47.5 VERSUS EXPECTED 59.9 UG/ML, SAMPLE 15 = 50.9 VERSUS EXPECTED 64.7 UG/ML , SAMPLE 23 = 40.5 VERSUS EXPECTED 52.3 UG/ML, SAMPLE 24 = 61.8 VERSUS EXPECTED 79.9, 77.7 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE PATIENT SAMPLE RESULTS IN QUESTION WERE OBTAINED AS PART OF VALP LOT TO LOT CORRELATION STUDY AND THEREFORE, NO PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER 2 OF 2 MDR¿S FOR THIS EVENT. TWO (2) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 2 DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797997 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN VITROS DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-6393

    Patients

    Seq Age Sex Outcome Treatment
    1