BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2072145 · Received April 28, 2011

    Report

    Report Number
    2954323-2011-03087
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 11, 2011
    Report Date
    June 14, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION AND THE STANDARD DEVIATION WAS WITHIN SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED THE CUSTOMER RECEIVED FOR A FEW DAYS READINGS ON HER PRECISION XTRA BLOOD GLUCOSE METER PERCEIVED AS "RANDOM INCONSISTENT READINGS" (READINGS ARE UNKNOWN) AND THEN WENT INTO A "DIABETIC SHOCK". THE REPORTED SYMPTOMS WERE CONFUSION, TALKING ODDLY AND STROKE LIKE SYMPTOMS. THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS REPORTEDLY TREATED WITH GLUCOSE ORALLY, AND SUBSEQUENTLY TRANSPORTED HER TO A HEALTH CARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH AN UNSPECIFIED INTRAVENOUS MEDICATION, "SOME MEDICINE" AND NEW DIET. ADC CUSTOMER SERVICE MADE LATER ATTEMPTS TO CONTACT THE CUSTOMER TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT, BUT THE CUSTOMER COULD NOT BE REACHED. 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 45001G178

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention