BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 2082258 · Received May 9, 2011

    Report

    Report Number
    2954323-2011-03214
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 15, 2011
    Report Date
    June 28, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (45001F068) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS 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 MANUFACTURE OF THE DEVICE IS UNKNOWN. IT SHOULD BE NOTED: THIS METER WAS DESIGNED TO PROVIDED READINGS BETWEEN 20 MG/DL - 500 MG/DL. A READING ABOVE 500 MG/DL WILL DISPLAY AS "HI" AND A READING BELOW 20 MGD/L WILL DISPLAY AS "LO".

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2011 AT 6:00 PM SHE RECEIVED A READING OF "HI" (A READING GREATER THAN 500 MG/DL) ON HER PRECISION XTRA BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN SHE FELT. SHE FURTHER REPORTED SELF-ADMINISTERING 20 UNITS OF INSULIN AND THEN ATE DINNER. CUSTOMER THEN RECHECKED HER GLUCOSE TWO HOURS LATER AND AGAIN RECEIVED A READING OF "HI". CUSTOMER THEN SELF-ADMINISTERED AN ADDITIONAL 10 UNITS OF INSULIN, BEGAN TO EXPERIENCE NAUSEA AND THEN SUBSEQUENTLY LOST CONSCIOUSNESS. CUSTOMER FELL WHEN SHE LOST CONSCIOUSNESS AND SUSTAINED A "BUMP" ON HER HEAD. PARAMEDICS WERE CALLED ADMINISTERED GLUCOSE VIA AN UNKNOWN ROUTE OF ADMINISTRATION, INITIATED AN INTRAVENOUS INFUSION OF UNKNOWN TYPE AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY. CUSTOMER REPORTS WAKING UP IN THE HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH ADDITIONAL INTRAVENOUS FLUIDS, (B)(6). CUSTOMER DENIED SELF-TREATING. CUSTOMER WAS KEPT OVERNIGHT FOR OBSERVATION. 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 45001F068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R