BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2921167 · Received January 17, 2013

    Report

    Report Number
    2954323-2013-00031
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 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 (1258244) 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THE METER'S DATE OF MANUFACTURE IS UNKNOWN. (B)(4). THE ACTUAL DATE WHEN THE EVENT OCCURRED IS UNCLEAR. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A PORT ISSUE AND NOTED THAT THREE DAYS PRIOR TO CALLING CUSTOMER SERVICE ON (B)(6) 2012 SHE WAS UNABLE TO PERFORM A TEST USING HER ADC BLOOD GLUCOSE METER BECAUSE WHEN SHE INSERTED A TEST STRIP OR PRESSED THE BUTTON ALL THAT HAPPENED WAS A BEEPING SOUND, BUT NOTHING SHOWED UP ON THE DISPLAY. CUSTOMER FURTHER REPORT EXPERIENCING "LIGHTHEADEDNESS" AND NOTED SHE "WAS NOT HEARING RIGHT". CUSTOMER INDICATED THE PROBLEM WITH THE METER ACTUALLY STARTED SEVERAL WEEKS PRIOR TO HER CALLING. CUSTOMER DENIED SELF-TREATING. PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL RECEIVED A READING OF 264 MG/DL ON THEIR UNKNOWN BRAND OF METER. AN INTRAVENOUS INFUSION OF UNKNOWN TYPE WAS INITIATED AND CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY. UPON ARRIVAL A SUBSEQUENT READING OF 464 MG/DL WAS RECEIVED. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH 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
    27018 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1258244

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R