BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMPH REAGENT

    MDR report key: 6198370 · Received December 22, 2016

    Report

    Report Number
    1319808-2016-00043
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 22, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT FOUR LOWER THAN EXPECTED VITROS AMPH PROFICIENCY SAMPLE RESULTS OCCURRED ON A VITROS 5600 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE IS A KNOWN LIMITATION OF THE VITROS AMPH REAGENT. THE MDMA COMPOUND PRESENT IN THE SAMPLES HAS A LOW CROSS REACTIVITY WITH THE VITROS AMPH REAGENT AS STATED IN THE VITROS AMPH INSTRUCTIONS FOR USE (IFU). THE VITROS 5600 SYSTEM DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED MULTIPLE LOWER THAN EXPECTED VITROS AMPH RESULTS OBTAINED FROM TWO PROFICIENCY SAMPLES PROCESSED ON A VITROS 5600 CHEMISTRY SYSTEM. SAMPLE UDS-A-01-VITROS AMPH RESULTS OF 272, AND 260 NG/ML VERSUS EXPECTED POSITIVE RESULTS (>1000 NG/ML). SAMPLE UDS-A-04-VITROS AMPH RESULTS OF 363 AND 384 NG/ML VERSUS EXPECTED POSITIVE RESULTS (>1000 NG/ML). THE CUSTOMER MADE NO ALLEGATIONS THAT PATIENT SAMPLE RESULTS WERE AFFECTED. HOWEVER, BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF OCCURRED UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849216 VITROS CHEMISTRY PRODUCTS AMPH REAGENT IN VITRO DIAGNOSTICS DKZ ORTHO-CLINICAL DIAGNOSTICS 1521-07-5451

    Patients

    Seq Age Sex Outcome Treatment
    1