BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CRP SLIDES

    MDR report key: 12706582 · Received October 27, 2021

    Report

    Report Number
    1319809-2021-00157
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 27, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A LOWER THAN EXPECTED VITROS CRP RESULT WAS OBTAINED FROM A NEONATAL PATIENT SAMPLE TESTED WITH VITROS CRP SLIDE LOT 3771-1119-2875 ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE RESULT OBTAINED USING VITROS CRP LOT 3768-1106-9689 ON THE SAME VITROS XT7600 SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED RESULT IS UNKNOWN. A POSSIBLE CAUSE IS LOT TO LOT DIFFERENCES IN COMBINATION WITH DIFFERENT CALIBRATOR FLUIDS USED FOR CALIBRATION OF BOTH VITROS CRP LOTS IN USE CONTRIBUTED TO THE BIAS. HISTORICAL QUALITY CONTROL RESULTS ARE NOT AVAILABLE FOR VITROS CRP LOT 3771-1119-2875 AS THE LOT WAS NOT IN USE AT THE TIME OF THE EVENT. HOWEVER, QUALITY CONTROL RESULTS PERFORMED ON THE DAY OF THE EVENT WERE WITHIN EXPECTATION, AND THE CURRENT QUALITY CONTROL PERFORMANCE OF THIS LOT IS WELL WITHIN EXPECTATION WHEN COMPARED TO THE MAS PEER RESULTS. THE CUSTOMER CONTINUES TO RUN VITROS CRP LOT 3771-1119-2875 WITHOUT ISSUE. ADDITIONALLY, HISTORICAL QUALITY CONTROL RESULTS FOR THE CUSTOMERS PREVIOUS LOT OF VITROS CRP WERE WITHIN EXPECTATION. THIS INDICATES THAT THE VITROS XT7600 WAS PERFORMING AS EXPECTED IN COMBINATION WITH THE PREVIOUS LOT OF VITROS CRP REAGENT, AND IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED AT THE TIME OF THE EVENT, THEREFORE AN UNKNOWN TRANSIENT INSTRUMENT PERFORMING ISSUE CANNOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR TO THE LOWER THAN EXPECTED RESULT. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS CRP LOT 3771-1119-2875. (B)(6).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A LOWER THAN EXPECTED VITROS CRP RESULT WAS OBTAINED FROM A NEONATAL PATIENT SAMPLE TESTED WITH VITROS CRP SLIDE LOT 3771-1119-2875 ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULT WAS LOWER THAN EXPECTED WHEN COMPARED TO THE RESULT OBTAINED USING VITROS CRP LOT 3768-1106-9689 ON THE SAME VITROS XT7600 SYSTEM. PATIENT SAMPLE RESULT OF <0.5 MG/DL VS. THE EXPECTED RESULT OF 1.1 MG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED VITROS CRP RESULT WAS OBTAINED DURING TROUBLESHOOTING AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION 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
    1606287 VITROS CHEMISTRY PRODUCTS CRP SLIDES IN-VIRO DIAGNOTICS DCK ORTHO-CLINICAL DIAGNOSTICS 3771-1119-2875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown