BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS GLU SLIDES

    MDR report key: 6502913 · Received April 19, 2017

    Report

    Report Number
    1319809-2017-00043
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Date of Event
    March 21, 2017
    Report Date
    April 19, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED, NON-REPRODUCIBLE GLUCOSE RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES USING VITROS CHEMISTRY PRODUCTS GLU SLIDES ON A VITROS 5600 SYSTEM. THE DEFINITIVE ASSIGNABLE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED, IT IS SUSPECTED THAT THE FIRST 2 SLIDES FROM THIS CARTRIDGE MAY HAVE BEEN COMPROMISED, ALTHOUGH THIS CANNOT BE CONFIRMED. AN INVESTIGATION HAS BEEN INITIATED TO REVIEW THE MANUFACTURING EVENT, AND THE RESULTS OF THE REVIEW WILL BE SENT IN A SUPPLEMENTAL REPORT ONCE COMPLETED. THIS IS MOST LIKELY AN ISOLATED EVENT SINCE NO SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED FOR THIS LOT. THERE WAS NO EVIDENCE TO SUGGEST A SYSTEMIC ISSUE WITH THE VITROS GLU REAGENT OR THE VITROS 5600 INTEGRATED SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED LOWER THAN EXPECTED, NON-REPRODUCIBLE GLUCOSE RESULTS ON TWO DIFFERENT PATIENT SAMPLES PROCESSED USING VITROS GLU SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 1 GLU RESULT <20 MG/DL VERSUS AN EXPECTED RESULT OF 119.7 MG/DL. PATIENT 2 GLU RESULT <20 MG/DL VERSUS AN EXPECTED RESULT OF 113.6 MG/DL. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER THAN EXPECTED RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY, AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE AFFECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284467 VITROS CHEMISTRY PRODUCTS GLU SLIDES IN-VITRO DIAGNOSTIC CGA ORTHO-CLINICAL DIAGNOSTICS 0032-0924-6548

    Patients

    Seq Age Sex Outcome Treatment
    1