BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1960596 · Received January 13, 2011

    Report

    Report Number
    2954323-2011-00605
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 29, 2010
    Report Date
    March 1, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    AS THE REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED.

    Description of Event or Problem · 1

    THE CUSTOMER'S CAREGIVER REPORTED THE PATIENT RECEIVED AN UNKNOWN ERRATIC READING ON THEIR BLOOD GLUCOSE METER. IT WAS ADDITIONALLY REPORTED THE CUSTOMER INJECTED AN UNSPECIFIED AMOUNT OF INSULIN AND HAD A MINOR STROKE. IT WAS ALSO REPORTED THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS REPORTEDLY TREATED WITH GLUCOSE (ROUTE OF ADMINISTRATION IS UNKNOWN), AND ALSO WITH INSULIN WHICH IS INCONSISTENT WITH THE TREATMENT OF GLUCOSE MENTIONED ON THE SAME REPORT. NO FURTHER INFORMATION ABOUT THE EVENT IS AVAILABLE AT THIS MOMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A451

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R