BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA STATSENSOR CREATININE HOSPITAL METER

    MDR report key: 2506034 · Received March 22, 2012

    Report

    Report Number
    1219029-2012-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 12, 2012
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CGL
    PMA / PMN Number
    K070068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INTERNAL INVESTIGATION ((B)(4)) TEST RESULTS SHOWED THAT THE RETAINS OF THE CUSTOMER CREATININE TEST STRIP LOT (LOT# 4911180249) MET THE DEFINED 510K CLEARANCE ACCEPTANCE CRITERIA FOR BOTH WHOLE BLOOD AND QUALITY CONTROL TESTING. THERE WERE NO OBVIOUS RESULT DISCREPANCIES OBSERVED AT ANY CREATININE LEVEL IN THE INVESTIGATION. IN SUMMARY, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THAT INFORMATION WAS REPORTED TO THE INITIAL REPORTER.

    Description of Event or Problem · 1

    IT WAS DETERMINED BY THE HOSPITAL THAT A SINGLE NOVA STATSENSOR HOSPITAL METER CREATININE CAPILLARY PT RESULT WAS CLINICALLY SIGNIFICANTLY DIFFERENT THAN THE RESULT OBTAINED FROM A VENOUS SAMPLE FROM THE SAME PT ON THE HOSPITAL LABORATORY ANALYZER (SIEMEN ADVIA). PT; STATSENSOR RESULT: 0.75 MG/DL, LAB RESULT: 1.57 MG/DL. THE HOSPITAL THRESHOLD FOR THE ALLOWANCE OF THE ADMINISTRATION OF CONTRAST MEDIA IS A RESULT BELOW 1.50 MG/DL. THEREFORE THE PT WAS GIVEN CONTRAST MEDIA BASED ON THE RESULT FORM THE METER. PER THE REPORTER, THE PT WAS GIVEN IV SOLUTION TO DIFFUSE THE MEDIA AND WAS RELEASED TO GO HOME. AS OF THE DATE OF THIS REPORT, NO ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA STATSENSOR CREATININE HOSPITAL METER CGL - CREATININE TEST SYSTEM CGL NOVA BIOMEDICAL 43370 4911180249

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other