BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT PROFILE CRITICAL CARE XPRESS

    MDR report key: 3131224 · Received May 23, 2013

    Report

    Report Number
    1219029-2013-00002
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 29, 2013
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    CHL
    PMA / PMN Number
    K022746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL PERFORMED AN INTERNAL INVESTIGATION ((B)(4)) OF MANUFACTURER RETAINS OF TWO LOTS OF CCX CREATININE MEMBRANES (PN 35238 LOTS 303191 AND 304263) THAT WERE IN USE AT THE USER FACILITY. ALL CREATININE MEMBRANES WERE QUALIFIED. ALL WHOLE BLOOD CREATININE RESULTS MET THE ACCEPTANCE CRITERIA. ALSO THIS INVESTIGATION TESTED THE VACUTAINER TUBES IN USE BY THE END USER. TUBES WERE OBTAINED FROM THE END USER FOR THIS TEST. ALL WHOLE BLOOD CREATININE RESULTS MET THE ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    END USER STATED THAT THE STAT PROFILE CRITICAL CARE XPRESS ANALYZER REPORTED CREATININE PATIENT RESULTS THAT WERE HIGHER THAN THE REFERENCE ANALYZER. THE RESULTS DIFFERENCE WERE CLINICALLY SIGNIFICANT. THREE PATIENTS WERE ADMITTED TO THE HOSP BASED ON THE HIGHER RESULTS. THE END USER DID NOT REPORT IF ANY ACTION WAS TAKEN DUE TO THE ADMITTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229201 STAT PROFILE CRITICAL CARE XPRESS CHL NOVA BIOMEDICAL CORP. 35942 Y01907070

    Patients

    Seq Age Sex Outcome Treatment
    1