BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVA STATSENSOR CREATININE HOSPITAL METER

    MDR report key: 1970278 · Received January 14, 2011

    Report

    Report Number
    1219029-2010-00006
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 16, 2010
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CGL
    PMA / PMN Number
    K070068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL OPENED A CUSTOMER COMPLAINT FILE FOR THIS INCIDENT ((B)(4)) FOLLOWING NOVA BIOMEDICAL OPERATING PROCEDURE 159. NOVA BIOMEDICAL QUALITY ASSURANCE GROUP PERFORMED A DEVICE HISTORY FILE REVIEW OF THE MANUFACTURING RECORDS OF THE AFFECTED LOT OF TEST STRIPS. THE DEVICE HISTORY FILE WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PLACED INTO FINISHED GOODS MET ALL SPECIFICATIONS. NOVA BIOMEDICAL PERFORMED AN INTERNAL INVESTIGATION ((B)(4)) OF THE AFFECTED TEST STRIP LOT RETAINS. THE TEST RESULTS SHOWED THAT THE RETAINED CREATININE TEST STRIPS FROM LOT # 4910273249 MET THE DEFINED ACCEPTANCE CRITERIA FOR BOTH WHOLE BLOOD AND QUALITY CONTROL TESTING. THERE WAS NO OBVIOUS RESULT DISCREPANCIES OBSERVED AT ANY CREATININE LEVEL IN THE INVESTIGATION. THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    A PT THAT HAD RENAL INSUFFICIENCY HAD A NOVA STATSENSOR CREATININE BLOOD TEST PERFORMED ON (B)(6) 2010. THE REPORTED RESULT WAS 0.90 MG/DL. BASED ON THE RESULT, THE PT RECEIVED CONTRAST MEDIA FOR AN IMAGING TEST. THE PT WAS ADMITTED TO THE HOSPITAL ON THE NEXT DAY. AFTER ADMITTANCE, THE CENTRAL LABORATORY, UTILIZING A BECKMAN LX20 ANALYZER, REPORTED CREATININE RESULTS OF 4.51 AND 4.44 MG/DL ON (B)(6) 2010 AND 4.48 MG/DL ON (B)(6) 2010. IT WAS REPORTED TO NOVA BIOMEDICAL THAT THE AFFECTED PT HAS BEEN RELEASED FROM THE HOSPITAL.

    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 4910273249

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other