BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1972089 · Received January 27, 2011

    Report

    Report Number
    2954323-2011-01225
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 29, 2010
    Report Date
    March 1, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. METER POWERED ON WITH BUTTON AND WITH INSERTION OF BOTH CAL BAR AND STRIPS. DID NOT OBSERVE METER TURN OFF AFTER CAL BAR OR STRIPS WERE INSERTED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED A PORT ISSUE WITH THEIR PXTRA METER TURNING ON AND THEN OFF WHEN THE TEST STRIP WAS INSERTED. THE CUSTOMER STATED THAT AS A RESULT HE WAS UNABLE TO CHECK HIS BLOOD GLUCOSE OR SELF-TREAT WITH INSULIN. THE CUSTOMER THEN REPORTED FEELING LIGHTHEADED AND PARAMEDICS WERE CALLED. CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY, DIAGNOSED WITH HYPOGLYCEMIA AND "GIVEN FLUIDS" AND (3) DEX4 GLUCOSE TABLETS. THE CUSTOMER COULD NOT RECALL THE SPECIFIC FLUIDS GIVEN AT THE HOSPITAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45643

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention