BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2092035 · Received May 18, 2011

    Report

    Report Number
    2954323-2011-03299
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 10, 2011
    Report Date
    July 20, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(6)) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER'S PHYSICIAN CALLED CUSTOMER SERVICE ON (B)(6) 2011 AND REPORTED CUSTOMER EXPERIENCED THREE EPISODES OF A LOSS OF CONSCIOUSNESS AFTER RECEIVING HIGHER THAN FEELS READINGS FROM HIS PRECISION XTRA BLOOD GLUCOSE METER. CALLER REPORTED THAT ON (B)(6) 2011 CUSTOMER RECEIVED A READING OF 353 MG/DL AND SELF-TREATED WITH AN UNKNOWN AMOUNT OF INSULIN. FIVE HOURS LATER HE RECEIVED A READING OF 20 MG/DL AND LOST CONSCIOUSNESS. CALLER ALSO NOTED CUSTOMER RECEIVED READINGS OF 346 MG/DL ((B)(6) 2011) AND 423 MG/DL ((B)(6) 2011) AND SUBSEQUENTLY LOST CONSCIOUSNESS AFTER EACH READING. IT IS UNKNOWN IF CUSTOMER SELF-TREATED WITH INSULIN AFTER THE SECOND AND THIRD READINGS THAT WERE REPORTED. PARAMEDICS WERE CALLED EACH TIME AND ADMINISTERED GLUCOSE VIA 0.9% NACL INTRAVENOUS INFUSION. CUSTOMER DECLINED TO BE TRANSPORTED TO THE HOSPITAL. CUSTOMER ADDITIONALLY SELF-TREATED WITH FOOD. 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 45001F024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R