BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1992693 · Received February 15, 2011

    Report

    Report Number
    2954323-2011-01643
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 13, 2010
    Report Date
    April 7, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THE CUSTOMER RECEIVED A READING OF 236 MG/DL ON HER PRECISION XTRA BLOOD GLUCOSE METER AND THE READING HIGHER THAN SHE FELT. THE CUSTOMER REPORTEDLY LOST CONSCIOUSNESS WHILE SHE WAS AT SCHOOL. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO MEDICATIONS WERE REPORTEDLY TAKEN TO COUNTERACT THE EVENT. 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 45001A739

    Patients

    Seq Age Sex Outcome Treatment
    1 Other