BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3250932 · Received July 29, 2013

    Report

    Report Number
    2954323-2013-00404
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 5, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WAS RETUREND AND INVESTIGATED WITH RETAINED TEST STRIPS. METER POWERED ON WITH BUTTON DEPRESSION AND TEST STRIP INSERTION. NO NEW ISSUES WERE OBSERVED. BLANK SCREEN WAS NOT OBSERVED. THE COMPLAINT WAS 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. IT SHOULD BE NOTED THAT TEST STRIPS WERE EXPIRED (EXPIRATION DATE APRIL 30, 2010).

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S WIFE) REPORTED THAT CUSTOMER WAS UNABLE TO TEST DUE TO HIS ADC METER NOT TURNING ON WHEN THE BUTTON WAS PRESSED OR UPON TEST STRIP INSERTION AND THE METER DID NOT WORK FOR ABOUT 2 WEEKS PRIOR TO THE MEDICAL EVENT. IT WAS FURTHER REPORTED THAT CUSTOMER WAS TREATED WITH "40-50 UNITS LANTUS" AND EXPERIENCED SYMPTOMS THAT WERE DESCRIBED AS "TREMBLING, SWEATING, HIGH FEVER AND SHIVERING" AND HAD A LOSS OF CONSCIOUSNESS. CUSTOMER ALSO "WAS HALLUCINATING SAYING HE SEES WHITE THINGS AROUND HIM AND THEIR SON WHO WAS NOT AROUND THAT TIME". CUSTOMER'S FOOT (RIGHT HEEL) WAS "HUGE BECAUSE OF ULCERS CAUSED BY HIS DIABETES". CUSTOMER WAS TRANSPORTED TO A DOCTOR WHO EXAMINED HIM AND THEN CUSTOMER WAS TAKEN TO A HOSPITAL AND DIAGNOSED WITH HYPERGLYCEMIA. CALLER REPORTED THAT CUSTOMER'S TREATMENT AT A LOCAL HEALTH CARE FACILITY WAS: " X-RAY OF HIS CHEST AND A CATHETER WAS INSERTED IN HIS HEART'S VEIN TO INJECT ANTIBIOTIC", "LORATAB FOR PAIN HALF PILL FOR EVERY 6 HOURS", "DEMEROL INJECTION ON HIS GLUTEUS MUSCLE EVERY 4 HOURS AS NEEDED FOR PAIN SINCE LORATAB IS NOT WORKING FOR HIM AND INSULIN". CALLER ALSO STATED THAT ON (B)(6) 2013 CUSTOMER WENT TO SURGERY TO "REMOVE ULCERATIONS ON HIS RIGHT HEEL". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353990 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0809625

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R