BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER

    MDR report key: 1534738 · Received November 18, 2009

    Report

    Report Number
    1219029-2009-00004
    Event Type
    Other
    Date Received
    November 18, 2009
    Date of Event
    October 15, 2009
    Report Date
    October 22, 2009
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CGA
    PMA / PMN Number
    K070960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVEN THOUGH PROPER USAGE OF THIS METER WOULD NOT ALLOW FOR A USER TO MISINTERPRET A PRESENTATION OF THE SOFTWARE VERSION AS A PT RESULT, NOVA BIOMEDICAL HAS INITIATED A PROACTIVE PRODUCT CHANGE AS TO HOW THE SOFTWARE VERSION IS PRESENTED TO THE USER DURING METER INITIALIZATION. THE CHANGE DISPLAYS THE SOFTWARE VERSION WITH ALPHA CHARACTERS INSTEAD OF NUMERIC CHARACTERS. FOR EXAMPLE, THE SOFTWARE VERSION WILL PRESENT ITSELF AS "AA". THIS GOING FORWARD PRODUCT CHANGE WAS RELEASED ON OCT 5, 2009 TO MFG UNDER ENGINEERING CHANGE ORDER (B)(4). NOVA BIOMEDICAL WILL ALSO INCLUDE THE FOLLOWING STATEMENTS WITHIN THE INSTRUCTIONS FOR USE (IFU): THIS STATEMENT WILL BE PRESENTED IN THE METER SET-UP SECTION OF THE IFU: CAUTION: UPON INSTALLING THE BATTERY, THE METER SOFTWARE VERSION IS DISPLAYED FOR 3 SECONDS. SOFTWARE VERSION MAY BE NUMERIC (EXAMPLE 5.0); THEREFORE, PLEASE EXERCISE CAUTION TO ENSURE THE SOFTWARE VERSION IS NOT MISTAKEN FOR A GLUCOSE RESULT. THIS STATEMENT WILL BE PRESENTED IN THE METER TROUBLESHOOTING SECTION OF THE IFU: CAUTION: ATTEMPTS TO PERFORM GLUCOSE TESTING WITH A LOW BATTERY COULD RESULT IN THE SOFTWARE REBOOTING. UPON REBOOTING, THE SOFTWARE VERSION IS DISPLAYED FOR 3 SECONDS. SOFTWARE VERSION MAY BE NUMERIC (EXAMPLE 5.0); THEREFORE, PLEASE EXERCISE CAUTION TO ENSURE THE SOFTWARE VERSION IS NOT MISTAKEN FOR A GLUCOSE RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL CORP. ON (B)(4) 2009 THAT THE USER OF A DEVICE IN (B)(6) MISINTERPRETED THE PRESENTATION OF THE SOFTWARE VERSION OF THE DEVICE (5.0) AS A PT VALUE DURING PRODUCT INITIALIZATION AND ADMINISTRATED IMPROPER TREATMENT TO A PT. UPON INSERTION OF A TEST STRIP WHEN A "BATTERY LOW" ICON WAS PRESENT ON THE LCD, THE METER REINITIALIZED. DURING THIS PROCESS THE SOFTWARE VERSION OF THE DEVICE WILL BE PRESENTED ON THE SCREEN FOR ONLY 3 SECONDS WITH NO UNITS OF MEASURE VISIBLE. DURING PT ANALYSIS, THE PT RESULT IS PRESENTED ON THE SCREEN FOR UP TO 60 SECONDS WITH THE UNITS OF MEASUREMENT NEXT TO THE NUMERIC VALUE. THROUGH AN OFF LABELED USE OF THE DEVICE, THE USER MISINTERPRETED THE SOFTWARE VERSION AS 5.0 G/L EVEN THOUGH THIS DEVICE ONLY PRESENTS PT RESULTS IN MG/DL. THE PT WAS INJECTED WITH INSULIN. ONE HOUR LATER, THE PT WAS FOUND UNRESPONSIVE. AT THAT TIME, A TEST OF THE PT GAVE A BLOOD GLUCOSE READING OF 24 MG/DL. THE PT WAS GIVEN GLUCAGON AND SUGAR BY MOUTH AND BECAME FULLY RESPONSIVE AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER STATSTRIP XPRESS METER CGA NOVA BIOMEDICAL 43404

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention