BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE INSULINX

    MDR report key: 2893683 · Received January 2, 2013

    Report

    Report Number
    2954323-2013-00002
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    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 (1272743) 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

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. IT SHOULD BE NOTED: DURING TROUBLESHOOTING IT WAS REVEALED THE CUSTOMER WAS USING INCOMPATIBLE TEST STRIPS. ADDITIONALLY: THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. THE EVENT DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED THAT ON THE THURSDAY OR FRIDAY PRIOR TO CALLING CUSTOMER SERVICE ON (B)(6) 2012 CUSTOMER (A CHILD) BEGAN TO EXPERIENCE "A HEADACHE, CHEST PAIN, A STOMACH ACHE, BLURRED VISION AND VOMITING" AFTER EATING DINNER. A GLUCOSE TEST WAS PERFORMED USING CUSTOMER'S FREESTYLE INSULINX BLOOD GLUCOSE METER AND A "LO" (A READING LESS THAN 20 MG/DL) WAS DISPLAYED ON THE METER'S DISPLAY. CUSTOMER WAS GIVEN FOUR OUNCES OF JUICE, FOUR OR FIVE TIMES, BUT THE METER CONTINUED TO DISPLAY "LO". AT SOME POINT, THE METER CEASED TO TURN ON WITH TEST STRIP INSERTION OR WHEN THE BUTTON WAS PRESSED, SO CUSTOMER'S MOTHER TOOK CUSTOMER TO A LOCAL HEALTHCARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH AN INTRAVENOUS INFUSION OF UNKNOWN TYPE AND AN UNSPECIFIED AMOUNT OF INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW 1272743

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| O| R