BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CA SLIDES

    MDR report key: 8139243 · Received December 6, 2018

    Report

    Report Number
    1319809-2018-00149
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 6, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    CJY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS CALCIUM (CA) QUALITY CONTROL (QC) RESULTS WERE ATTAINED USING VITROS CHEMISTRY PRODUCTS CA SLIDES AND VITROS CHEMISTRY PRODUCTS PERFORMANCE VERIFIERS IN COMBINATION WITH A VITROS 350 CHEMISTRY SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INFORMATION AVAILABLE, A POTENTIAL CAUSE OF THIS EVENT IS A NON-REACTIVE CARTRIDGE WHERE THE INTEGRITY OF THE FOIL WRAPPER IS COMPROMISED DURING SHIPMENT OR STORAGE ON SITE, EXPOSING THE SLIDES TO AMBIENT CONDITIONS. HOWEVER, THIS COULD NOT BE VERIFIED. THE LOWER THAN EXPECTED VITROS CA RESULTS WERE ISOLATED TO TWO SLIDE CARTRIDGES FROM THE SAME BOX OF VITROS CA SLIDES. ACCEPTABLE VITROS CA RESULTS WERE OBTAINED FROM THE CARTRIDGES IN USE PRIOR TO THE AFFECTED CARTRIDGES AND USING AN ALTERNATE SLIDE CARTRIDGE (SAME LOT) AFTER THE AFFECTED SLIDE CARTRIDGES WERE UNLOADED FROM THE INSTRUMENT. A REVIEW OF HISTORICAL VITROS CA QUALITY CONTROL DATA INDICATED ACCEPTABLE QC PERFORMANCE APART FROM RESULTS OBTAINED FROM THE TWO SUSPECT VITROS CA CARTRIDGES. ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD SUGGEST THERE IS A SYSTEMIC ISSUE WITH VITROS CA SLIDE LOT 0313-0571-9275. WITHIN-RUN PRECISION TESTING USED TO ASSESS THE PERFORMANCE OF THE VITROS 350 CHEMISTRY SYSTEM WAS PERFORMED AND ACCEPTABLE RESULTS WERE ATTAINED. THEREFORE, AN INSTRUMENT ISSUE WAS RULED OUT AS A CONTRIBUTOR TO THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LOWER THAN EXPECTED VITROS CALCIUM (CA) QUALITY CONTROL (QC) RESULTS OBTAINED USING VITROS CHEMISTRY PRODUCTS CA SLIDES AND VITROS CHEMISTRY PRODUCTS PERFORMANCE VERIFIERS IN COMBINATION WITH A VITROS 350 CHEMISTRY SYSTEM. VITROS PERFORMANCE VERIFIER II LOT X5905 RESULTS OF 8.66, 8.49 AND 8.56 MG/DL VERSUS THE EXPECTED RESULT OF 12.1 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER 2 OF 3 MDR¿S FOR THIS EVENT. THREE (3) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 3 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979973 VITROS CHEMISTRY PRODUCTS CA SLIDES IN VITRO DIAGNOSTICS CJY ORTHO-CLINICAL DIAGNOSTICS 0313-0571-9275

    Patients

    Seq Age Sex Outcome Treatment
    1