BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12

    MDR report key: 7927550 · Received October 2, 2018

    Report

    Report Number
    1319808-2018-00029
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 2, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM THREE DIFFERENT LEVELS OF VITROS TDM PV QUALITY CONTROL FLUIDS USING VITROS VALP REAGENT, ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS VALP RESULTS OBTAINED USING VITROS TDM PV FLUIDS WAS DETERMINED TO BE CALIBRATION RELATED. THE RESPONSES AND PARAMETERS OF THE AFFECTED CALIBRATION APPEARED ATYPICAL TO EXPECTED RESPONSES AND PARAMETERS. RECALIBRATING WITH AN ALTERNATE SET OF CALIBRATORS FROM THE SAME LOT HAD RESOLVED THE ISSUE. THE DEFINITIVE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS TDM PV FLUID RESULTS WAS UNKNOWN, HOWEVER, PRE-ANALYTICAL SAMPLE MIX UP AND IMPROPER FLUID HANDLING PROTOCOL COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. WITHIN-RUN PRECISION TESTING USED TO ASSESS INSTRUMENT PERFORMANCE WAS NOT PERFORMED AND THEREFORE AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR. ACCEPTABLE RESULTS WERE OBTAINED FROM THE SAME REAGENT PACKS THAT INITIALLY GENERATED LOWER THAN EXPECTED RESULTS. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VALP REAGENT LOT 2511-25-6393. THEREFORE, A VITROS VALP REAGENT RELATED ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER AND LOWER THAN EXPECTED RESULTS FROM THREE DIFFERENT LEVELS OF VITROS TDM PERFORMANCE VERIFIER (PV) QUALITY CONTROL FLUIDS USING VITROS VALPROIC ACID (VALP) REAGENT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. HIGHER THAN EXPECTED RESULTS: VITROS TDM PV I (B)(4) RESULTS OF 277.5 AND 351.7 UMOL/L VS. THE EXPECTED RESULT OF 170 UMOL/L. VITROS TDM PV II (B)(4) RESULTS OF 602.2 AND 722.5 UMOL/L VS. THE EXPECTED RESULT OF 477.5 UMOL/L. VITROS TDM PV III (B)(4) RESULTS OF 1039.5 UMOL/L VS. THE EXPECTED RESULT OF 835 UMOL/L. LOWER THAN EXPECTED RESULTS: VITROS TDM PV I (B)(4) RESULTS OF <69.3 (X5) UMOL/L VS. THE EXPECTED RESULT OF 170 UMOL/L. VITROS TDM PV II (B)(4) RESULTS OF <69.3 (X5) AND 378.3 UMOL/L VS. THE EXPECTED RESULT OF 477.5 UMOL/L. VITROS TDM PV III (B)(4) RESULTS OF <69.3, <69.3, 81.9, 81.9, AND 137.6 UMOL/L VS. THE EXPECTED RESULT OF 835 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE ISSUE WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE UNEXPECTED VITROS VALP RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768359 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 12 IN-VITRO DIAGNOSTIC DLJ ORTHO-CLINICAL DIAGNOSTICS 1287

    Patients

    Seq Age Sex Outcome Treatment
    1