BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CREA SLIDES

    MDR report key: 7716248 · Received July 24, 2018

    Report

    Report Number
    1319809-2018-00100
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    June 23, 2018
    Report Date
    July 24, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JFY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREA RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM, WHEN COMPARED TO THE RESULT OBTAINED FROM A NON-VITROS ROCHE METHOD. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. HOWEVER, SINCE THE ISSUE WAS ISOLATED TO A SINGLE PATIENT SAMPLE, AN UNKNOWN SAMPLE INTERFERENT THAT AFFECTS THE VITROS ASSAY, BUT NOT THE NON-VITROS ROCHE METHOD, IS THE LIKELY CAUSE OF THE EVENT, BUT THIS COULD NOT BE CONFIRMED. THERE WAS NO INDICATION THE VITROS 5600 INTEGRATED SYSTEM MALFUNCTIONED, HOWEVER, SINCE NO WITHIN-RUN PRECISION PERFORMANCE TESTING WAS PROCESSED, AN INSTRUMENT RELATED ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. ADDITIONALLY, THE HISTORICAL QUALITY CONTROL DATA REVIEW INDICATES THE VITROS CREA SLIDES WERE PERFORMING AS INTENDED AND DID NOT LIKELY CONTRIBUTE TO THE EVENT. A DEFINITIVE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED REPRODUCIBLE, LOWER THAN EXPECTED VITROS CREATININE (CREA) RESULTS FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 INTEGRATED SYSTEM, WHEN COMPARED TO THE RESULT OBTAINED FROM A NON-VITROS ROCHE METHOD. VITROS CREA RESULTS OF 0.56 AND 0.46 MG/DL VS. THE EXPECTED RESULT OF 3.45 MG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED CREA RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THERE WERE NO REPORTED ALLEGATIONS OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBERS (B)(4) / QERTS RECORD ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559060 VITROS CHEMISTRY PRODUCTS CREA SLIDES IN-VITRO DIAGNOSTIC JFY ORTHO-CLINICAL DIAGNOSTICS 1515-3474-6084

    Patients

    Seq Age Sex Outcome Treatment
    1