BEUDAMED
    FDA Adverse Event Other Summary report: N

    STATSTRIP XPRESS METER

    MDR report key: 2068003 · Received April 13, 2011

    Report

    Report Number
    1219029-2011-00003
    Event Type
    Other
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 25, 2011
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    CGA
    PMA / PMN Number
    K070960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INFO FORWARDED TO THE MFR BY THE HOSPITAL, THE ROOT CAUSE OF THE INCORRECT BLOOD GLUCOSE RESULTS WHEN MEASURING FROM THE FINGERTIP WAS DUE TO DECREASED PERIPHERAL BLOOD FLOW DUE TO THE MULTIPLE ORGAN FAILURE. NOVA BIOMEDICAL PRODUCT LABELING (IFU AND TEST STRIP INSERT) STATES THAT "CAPILLARY BLOOD GLUCOSE TESTING MAY NOT BE APPROPRIATE FOR PERSONS WITH DECREASED PERIPHERAL BLOOD FLOW AS IT MAY NOT REFLECT THE TRUE PHYSIOLOGICAL STATE. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO, SEVERE HYPOTENSION, SHOCK, HYPEROSMOLAR-HYPERGLYCEMIA (WITH OR W/O KETOSIS) AND SEVERE DEHYDRATION." THE DEVICE PERFORMED AS INTENDED AND DID NOT CAUSE OR CONTRIBUTE TO THE PTS DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN (B)(6) OLD MALE WAS BROUGHT INTO THE EMERGENCY ROOM FOR HYPOGLYCEMIA. THE PT'S BLOOD GLUCOSE, WHEN TESTED AT THE FINGERTIP, WAS MEASURED BY THE STATSTRIP XPRESS METER AND THE REPORTED GLUCOSE RESULT WAS 24 MG/DL. BASED UPON THIS REPORTED RESULT, THE PHYSICIAN ADMINISTERED GLUCOSE BY IV TRANSFUSION (VEEN D 500ML + 50% GLUCOSE SOLUTION 40ML). BASED UPON CONTINUED LOW READINGS TAKEN FROM THE FINGERTIP MEASUREMENTS, ADD'L GLUCOSE WAS ADMINISTERED TO THE PT. DUE TO CONTINUED LOW GLUCOSE RESULTS REPORTED AT THE FINGERTIP, THE ATTENDING PHYSICIAN DECIDED TO PERFORM A GLUCOSE TEST ON THE STATSTRIP XPRESS USING A CAPILLARY SPECIMEN COLLECTED FROM THE PT'S EARLOBE. THE PHYSICIAN ALSO SENT A VENOUS SPECIMEN TO THE CENTRAL LABORATORY FOR TESTING. THE GLUCOSE RESULTS OBTAINED BY THE STATSTRIP XPRESS FROM THE EARLOBE (387 MG/DL) WERE SIMILAR TO THE RESULTS OBTAINED ON THE VENOUS SPECIMEN MEASURED IN THE CENTRAL LABORATORY (374 MG/DL). ADD'L INVESTIGATION DETERMINED THAT ALL BLOOD GLUCOSE RESULTS OBTAINED AT THE FINGERTIP WERE LOW WHEN COMPARED TO THE EARLOBE RESULTS OR THE CENTRAL LABORATORY RESULTS. AT THIS TIME, NO OTHER TREATMENT OR MEDICATION WAS GIVEN TO THE PT DUE TO FAMILY DETERMINATION AND THE PT DIED FROM MULTIPLE ORGAN FAILURE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATSTRIP XPRESS METER CGA NOVA BIOMEDICAL 47805

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other