BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVA STATSENSOR CREATININE HOSPITAL METER

    MDR report key: 3824458 · Received May 8, 2014

    Report

    Report Number
    1219029-2014-00002
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CGL
    PMA / PMN Number
    K070068
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS PERFORMED FOLLOWING NOVA PROTOCOL WHICH TESTED RETAINED STATSENSOR CREATININE TESTS STRIPS FROM THE LOT NUMBER THE CUSTOMER WAS UTILIZING AT THE TIME OF THE INCIDENT (CREATININE TEST STRIP LOT #4913302249). A TOTAL OF FIVE RESULT LEVELS OF NOVA STATSENSOR LINEARITY SOLUTIONS AND FIVE TARGET RANGE LEVELS OF BLOOD SAMPLES WERE TESTED. ACCEPTANCE CRITERIA: THE RESULTS WILL BE ACCEPTABLE IF ALL THE MEASUREMENTS OF THE NOVA STATSENSOR LINEARITY SOLUTIONS ARE WITHIN THEIR EXPECTED RANGE AND THE TEST STRIP LOT PASSES THE CLINICAL ACCURACY PERFORMANCE IF 95% OF THE OVERALL MEASURED RESULTS ARE FOUND TO BE WITHIN THE FOLLOWING CRITERIA: RESULTS >1.5 MG/DL ARE FOUND TO BE WITHIN +/-20% OF AVERAGE VITROS VALUE AND RESULTS </=1.5 MG/DL ARE FOUND TO BE WITHIN +/-0.3 MG/DL OF THE AVERAGE VITROS VALUE. CONCLUSION: THE TEST RESULTS SHOWED THAT THE RETAINED STATSENSOR CREATININE TEST STRIPS FROM LOT # 4913302249 MET THE DEFINED ACCEPTANCE CRITERIA FOR BOTH WHOLE BLOOD AND LINEARITY TESTING. THERE WAS NO OBVIOUS RESULT DISCREPANCIES OBSERVED AT ANY CREATININE LEVEL IN THE INVESTIGATION. IN SUMMARY, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE SENIOR QUALITY MANAGER PERFORMED A DEVICE HISTORY RECORD REVIEW FOR THE AFFECTED LOT OF STATSENSOR CREATININE TEST STRIPS. THE DEVICE HISTORY RECORD CONTAINED ALL RELEVANT DATA INDICATING THAT THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE HOSPITAL HAD A DISCREPANCY WITH THE CREATININE VALUES RECEIVED FROM THE NOVA STATSENSOR METER AND THE VITROS ANALYZER IN LAB. THE STATSENSOR GOT A RESULT OF 1.21 MG/DL AND THE PATIENT WAS GIVEN CONTRAST. THE RADIOLOGY TECH LATER LEARNED THAT THE PATIENT'S CR VALUE ACCORDING TO THE LAB ANALYZER WAS 3.4 MG/DL. THIS RESULT WAS CONFIRMED ON A DIFFERENT TUBE ON THE LAB ANALYZER. THE RADIOLOGY TECH THEN REPEATED THE VALUES WITH THE SAME TUBE OF BLOOD ON THE STATSENSOR METER AND RECEIVED RESULTS OF 1.72 AND 2.05 MG/DL. THE TUBE COLLECTED WAS A GEL LITHIUM HEPARIN TUBE AND WAS ALSO A SHORT DRAW. SINCE THE PATIENT WAS GIVEN CONTRAST MEDIA THE PATIENT WAS ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278225 NOVA STATSENSOR CREATININE HOSPITAL METER CREATININE TEST SYSTEM CGL NOVA BIOMEDICAL 4913302249

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization