BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2183363 · Received July 28, 2011

    Report

    Report Number
    2954323-2011-04031
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 3, 2011
    Report Date
    November 4, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED AND INVESTIGATED. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS OR NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ON (B)(6), 2011 THEY TRIED TO TEST THEIR BLOOD SUGAR AND THEIR PRECISION XTRA METER WOULD SHUT OFF AFTER SAMPLE APPLICATION; HOWEVER THEY ALSO REPORTED EVENTUALLY RECEIVING A READING OF 433 MG/DL THAT WAS HIGHER THAN THEY FELT. THE CUSTOMER FURTHER REPORTED THEY EXPERIENCED HEADACHE, LETHARGY, LIGHTHEADEDNESS AND WENT TO THE HOSPITAL WHERE THEY WERE DIAGNOSED WITH HYPERGLYCEMIA AND DKA (DIABETIC KETOACIDOSIS) AND TREATED WITH 12 UNITS OF FAST ACTING INSULIN TO COUNTERACT THE EVENT. IT SHOULD BE NOTED THE REPORTED READING WAS CONSISTENT WITH THE DIAGNOSIS AND TREATMENT RECEIVED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 47481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R