BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS OP REAGENT

    MDR report key: 6669466 · Received June 27, 2017

    Report

    Report Number
    1319808-2017-00010
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 27, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DJG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED DISCORDANT VITROS OP NEGATIVE RESULTS WERE OBTAINED FROM SAMPLES FROM THREE SEPARATE PATIENTS WHICH WERE REPORTED AS OP NEGATIVE WHEN THE PHYSICIAN EXPECTED A POSITIVE OP RESULT FROM ALL THREE PATIENTS WHEN TESTED ON A VITROS 5600 INTEGRATED CHEMISTRY SYSTEM. THE VITROS CHEMISTRY PRODUCTS OP ASSAY IS INTENDED FOR USE BY PROFESSIONAL LABORATORY PERSONNEL. IT PROVIDES ONLY A PRELIMINARY TEST RESULT. A MORE SPECIFIC ALTERNATIVE CHEMICAL METHOD MUST BE USED TO CONFIRM A RESULT OBTAINED WITH THIS ASSAY. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG-OF-ABUSE TEST RESULT. THE LIKELY CAUSE IS A KNOWN LIMITATION OF THE VITROS OP REAGENT RELATED TO LOW CROSS REACTIVITY WITH SYNTHETIC OPIOIDS. THE CUSTOMER DID NOT SEND THE SAMPLES FOR ADDITIONAL TESTING TO CONFIRM. THERE IS NO EVIDENCE TO SUGGEST THAT THE VITROS OP REAGENT LOT 1527-09-5708 MALFUNCTIONED. ALTHOUGH THERE IS NO INDICATION THAT THE INSTRUMENT WAS NOT PERFORMING AS INTENDED, AN INSTRUMENT ISSUE CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT. THERE IS NO INFORMATION TO SUGGEST THAT THE VITROS OP REAGENT MALFUNCTIONED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED UNEXPECTED DISCORDANT VITROS OP NEGATIVE RESULTS USING A <300 NG/ML CUTOFF FROM SAMPLES FROM THREE SEPARATE PATIENTS WHICH WERE REPORTED AS OP NEGATIVE WHEN THE PHYSICIAN EXPECTED A POSITIVE OP RESULT FROM ALL THREE PATIENTS DUE TO THEIR CONDITION (HEROIN OVERDOSE), ON A VITROS 5600 INTEGRATED CHEMISTRY SYSTEM. PATIENT 1 VITROS RESULT < 100 NG/ML (NEGATIVE) VERSUS AN EXPECTED POSITIVE RESULT (>300 NG/ML). PATIENT 2 VITROS RESULT < 100 NG/ML (NEGATIVE) VERSUS AN EXPECTED POSITIVE RESULT (>300 NG/ML). PATIENT 3 VITROS RESULT < 100 NG/ML (NEGATIVE) VERSUS AN EXPECTED POSITIVE RESULT (>300 NG/ML). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE DISCORDANT VITROS OP-LO RESULTS WERE REPORTED OUT OF THE LABORATORY. HOWEVER, THERE WAS NO REPORT OF TREATMENT STARTED, STOPPED, OR ALTERED BASED ON THE FALSE NEGATIVE VITROS OP-LO RESULTS AND THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452026 VITROS CHEMISTRY PRODUCTS OP REAGENT IN-VITRO DIAGNOSTIC DJG ORTHO-CLINICAL DIAGNOSTICS 1527-09-5708

    Patients

    Seq Age Sex Outcome Treatment
    1