BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1963073 · Received January 18, 2011

    Report

    Report Number
    2954323-2011-00706
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 22, 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

    THE CUSTOMER'S METER HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE NEW INFORMATION IS OBTAINED. THE MANUFACTURE DATE FOR THE METER LISTED IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    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

    A CUSTOMER REPORTED THAT THEY RECEIVED AN ADC PXTRA METER READING OF 288MG/DL THAT WAS "HIGHER THAN THEY FELT" AND REPORTEDLY EXPERIENCED AN INJURY . CUSTOMER STATED SPECIFICALLY, "BLOOD VESSELS BURST" IN ONE OF THEIR EYES AFTER RECEIVING THE READING AND THEY REPORTEDLY REQUIRED TREATMENT AT A HEALTH CARE FACILITY AND "LASER EYE SURGERY" TO CORRECT THE ISSUE. CUSTOMER THEN STATED THEY DID NOT WISH TO GIVE ANY ADDITIONAL INFORMATION. NO OTHER INFORMATION HAS BEEN PROVIDED. 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 45735

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention