BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS LI SLIDES

    MDR report key: 12245171 · Received July 29, 2021

    Report

    Report Number
    1319809-2021-00122
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 6, 2021
    Report Date
    July 29, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS LITHIUM (LI) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER QUALITY CONTROL FLUIDS AND TWO PATIENT SAMPLES PROCESSED USING VITROS LI SLIDE LOT 3128-0120-2296 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE INVESTIGATION DETERMINED THE ASSIGNABLE CAUSE OF THIS EVENT WAS DUE TO A NON-REACTIVE CARTRIDGE, WHERE THE INTEGRITY OF THE FOIL WRAPPER WAS COMPROMISED, EXPOSING THE SLIDES TO AMBIENT CONDITIONS. THE LOWER THAN EXPECTED VITROS LI RESULTS WERE ISOLATED TO A SINGLE SLIDE CARTRIDGE. THE EVENT IS CONSISTENT WITH A SLIDE CARTRIDGE THAT HAS BEEN EXPOSED TO AMBIENT CONDITIONS. ACCEPTABLE VITROS LI RESULTS WERE OBTAINED FROM THE CARTRIDGES IN USE PRIOR TO THE AFFECTED CARTRIDGE AND USING AN ALTERNATE SLIDE CARTRIDGE (SAME LOT) AFTER THE EFFECTED SLIDE CARTRIDGE WAS UNLOADED FROM THE INSTRUMENT. THE CUSTOMER INSPECTED THE CARTRIDGE FOIL WRAPPER AND IDENTIFIED A PUNCTURE. THE CAUSE OF THE PUNCTURE IN THE FOIL WRAPPER WAS NOT DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS LITHIUM (LI) RESULTS WERE OBTAINED FROM VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL FLUIDS AND TWO PATIENT SAMPLES PROCESSED USING VITROS LI SLIDE LOT 3128-0120-2296 ON A VITROS XT 7600 INTEGRATED SYSTEM. (B)(6). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NEGATIVELY BIASED LI RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR THE TWO PATIENT SAMPLES; HOWEVER, LI TESTING WAS REPEATED USING A NEW VITROS LI SLIDE CARTRIDGE FROM THE SAME LOT AND CORRECTED REPORTS WERE ISSUED. THERE WERE NO ALLEGATIONS 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
    1147386 VITROS CHEMISTRY PRODUCTS LI SLIDES IN-VITRO DIAGNOSTICS JIH ORTHO-CLINICAL DIAGNOSTICS 3128-0120-2296

    Patients

    Seq Age Sex Outcome Treatment
    1