BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12

    MDR report key: 7420521 · Received April 11, 2018

    Report

    Report Number
    1319808-2018-00013
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    March 19, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 (B)(4) OFFICE WAS NOTIFIED OF THIS ISSUE ON 12 DECEMBER 2018. PLEASE REFER TO REPORT #(B)(4).

    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 LOWER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED FROM NON-VITROS BIORAD CONTROL FLUIDS AND VITROS TDM PERFORMANCE VERIFIERS (TDM PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-25-6393 ON A VITROS 5600 INTEGRATED SYSTEM S/N (B)(4). THE MOST LIKELY ASSIGNABLE CAUSE IS A SUBOPTIMAL CALIBRATION DUE TO AN ISSUE WITH VITROS CALIBRATOR KIT 12, LOT 1266, AS THE CUSTOMER OBTAINED ACCEPTABLE PERFORMANCE WHEN USING VITROS VALP LOT 2511-25-6393 AFTER CALIBRATION WITH AN ALTERNATIVE LOT OF CALIBRATOR KIT 12. THERE IS NO INDICATION THAT A VALP REAGENT OR INSTRUMENT ISSUE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS OBTAINED FROM NON-VITROS BIORAD CONTROL FLUIDS AND VITROS TDM PERFORMANCE VERIFIERS (TDM PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD L1 LOT 31841 VITROS VALP RESULTS 18.87, 17.66, 17.93, AND 16.64 UG/ML VERSUS BASELINE; MEAN 28.91 UG/ML. BIORAD L2 LOT 31842 VITROS VALP RESULTS 96.34, 99.44, 98.20, 94.15, 93.56, 109.6 UG/ML VERSUS; BASELINE MEAN 137.2 UG/ML. VITROS TDM PERFORMANCE VERIFIER III LOT X6157 VITROS VALP RESULT 83.6 UG/ML VERSUS THE MIDPOINT OF THE ROM 113.6 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. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM DUE TO THE EVENT. HOWEVER THE INVESTIGATION CANNOT RULE OUT THAT PATIENT RESULTS WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4)/QERTS RECORD ID (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264683 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12 IN-VITRO DIAGNOSTIC DLJ ORTHO-CLINICAL DIAGNOSTICS 1266

    Patients

    Seq Age Sex Outcome Treatment
    1