BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2083873 · Received May 11, 2011

    Report

    Report Number
    2954323-2011-03228
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 22, 2011
    Report Date
    July 8, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (45001G169) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE REPORTED METER WAS RETURNED AND INVESTIGATED 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. THE COMPLAINT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF THE DEVICE'S MANUFACTURE IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2011 HE RECEIVED A READING OF 283 MG/DL ON HIS PRECISION XTRA BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN HE FELT. HE FURTHER REPORTED SUBSEQUENTLY EXPERIENCING A HEADACHE AND A SEIZURE. NO THIRD-PARTY EMERGENT MEDICAL INTERVENTION WAS REPORTED. CUSTOMER SELF-TREATED BY DRINKING JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001G169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other