BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 6790984 · Received August 14, 2017

    Report

    Report Number
    1319808-2017-00013
    Event Type
    Malfunction
    Date Received
    August 14, 2017
    Date of Event
    July 18, 2017
    Report Date
    January 4, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 HAS DETERMINED THAT A LOWER THAN EXPECTED VITROS VALP RESULT WAS OBTAINED FROM A SINGLE PATIENT CORRELATION SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT, LOT 2511-25-5727 ON VITROS 5600 INTEGRATED SYSTEM S/N (B)(4). THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN, HOWEVER, IMPROPER PRE ANALYTICAL SAMPLE STORAGE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IT IS UNKNOWN IF THE AFFECTED SAMPLE WAS STORED USING THE PROTOCOL STATED IN THE VITROS CHEMISTRY PRODUCTS VALP REAGENT INSTRUCTIONS FOR USE. IN ADDITION, A CALIBRATION RELATED ISSUE OR AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE ISSUE WAS RESOLVED AFTER PERFORMING THE ROUTINE MAINTENANCE ACTIONS OF REPLACING THE PHOTOMETER LAMP, PERFORMING A WATER BLANK PROCEDURE, AND RECALIBRATING VITROS CHEMISTRY PRODUCTS VALP REAGENT, LOT 2511-25-5727.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT A LOWER THAN EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT CORRELATION SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 2 RESULT OF 24 UG/ML VERSUS AN EXPECTED RESULT OF 34.0 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. THE CUSTOMER MADE NO INDICATION THAT ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571392 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-25-5727

    Patients

    Seq Age Sex Outcome Treatment
    1