BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 11923197 · Received June 2, 2021

    Report

    Report Number
    1319809-2021-00096
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 2, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS VANC PATIENT RESULT WAS OBTAINED USING A VITROS 5600 INTEGRATED SYSTEM IN COMBINATION WITH VANC LOT 2514-42-8534. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VANC REAGENT LOT 2514-42-8534. THE HISTORICAL QUALITY CONTROL DATA INDICATES THAT VITROS VANC LOT 2514-42-8534 WAS PERFORMING AS EXPECTED AND A VANC ISSUE WAS RULED OUT AS A CONTRIBUTOR TO THE EVENT. THE CUSTOMER PERFORMED WITHIN RUN DIAGNOSTIC PRECISION TESTING AND ACCEPTABLE PRECISION RESULTS WERE OBTAINED FROM VITROS GENT INDICATING THE VITROS 5600 SYSTEM WAS PERFORMING AS EXPECTED. HOWEVER, THE VANC WITHIN RUN PRECISION RESULTS WERE UNACCEPTABLE. THE TSC NOTED THAT THE VANC RESULTS SHIFTED HIGH WITHIN RUN BUT THE VANC RESULTS ARE PRECISE WITHIN EACH CUP AND THE RESULTS FROM THE FIRST 2 CUPS WERE LOWER THAN THE LAST 3 CUPS. IT IS POSSIBLE THAT SAMPLE CUPS SAT TOO LONG ON THE ANALYZER OR THE SAMPLE POURS WERE FROM DIFFERENT QC VIALS WITH SLIGHTLY DIFFERENT VANC CONCENTRATIONS. PRE-ANALYTICAL SAMPLE HANDLING COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. THE CUSTOMER IS USING SERUM SEPARATOR TUBES FOR SAMPLE COLLECTION. THE VITROS VANC INSTRUCTIONS FOR USE HAS THE FOLLOWING PRECAUTION: EACH LAB SHOULD EVALUATE THE SUITABILITY OF SERUM SEPARATORS OR ANY BLOOD COLLECTION DEVICE BEFORE USE IN THERAPEUTIC DRUG MONITORING. (B)(4)

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) PATIENT RESULT WAS OBTAINED USING A VITROS 5600 INTEGRATED SYSTEM IN COMBINATION WITH VANC LOT 2514-42-8534. VITROS VANC = <5.0 VERSUS 15.11, 18.00 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 LOWER THAN EXPECTED VITROS VANC RESULT WAS NOT 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 (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822664 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS 2514-42-8534

    Patients

    Seq Age Sex Outcome Treatment
    1