BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1732685 · Received June 22, 2010

    Report

    Report Number
    2954323-2010-00844
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    July 4, 2010
    Report Date
    August 11, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED THAT THE CUSTOMER WAS REPORTEDLY ATTEMPTING TO USE INCOMPATIBLE TEST STRIPS WITH HER BLOOD GLUCOSE METER. ADC CUSTOMER SERVICE EDUCATED THE CALLER ABOUT TEST STRIP COMPATIBILITY. THIS CASE DOES NOT INVOLVE A PRODUCT MALFUNCTION AND NO PRODUCT INVESTIGATION IS REQUIRED. THIS IS THE FINAL REPORT. NOTE: CUSTOMER'S DAUGHTER REPORTED CUSTOMER WAS USING INCOMPATIBLE FREESTYLE CLASSIC TEST STRIPS (LOT# 0907006) WITH THEIR FREESTYLE FREEDOM LITE METER (B) (4).

    Additional Manufacturer Narrative · 1

    ON JUNE 22ND, 2010, AN INITIAL MDR WAS FILED AS A SERIOUS INJURY REPORTING THAT THE CUSTOMER'S DAUGHTERS CALLED ADC CUSTOMER SERVICE ON (B)(6) 2010 AND REPORTED THE CUSTOMER PURCHASED TESTS STRIPS FROM AN UNKNOWN SOURCE TO USE WITH THEIR BLOOD GLUCOSE METER. THE METER WOULD TURN ON WITH THE BUTTON, BUT NOT WHEN A TEST STRIP WAS INSERTED INTO THE PORT. DURING THE TROUBLESHOOTING SURVEY, ADC CUSTOMER SERVICE IDENTIFIED THAT THE PURCHASED TEST STRIPS (FREESTYLE CLASSIC TESTS STRIPS: LOT # 0907006) WERE INCOMPATIBLE WITH THE CUSTOMER'S BLOOD GLUCOSE METER (FREESTYLE FREEDOM LITE: (B)(4). IT WAS ADDITIONALLY REPORTED THAT THE CUSTOMER EXPERIENCED A MEDICAL EVENT ON (B)(6) 2010 WHEN THEY WERE "ABOUT TO TAKE THEIR INSULIN AND LOST CONSCIOUSNESS". THE PARAMEDICS WERE CALLED AND THE CUSTOMER WAS REPORTEDLY TREATED WITH AN UNSPECIFIED SHOT AND SOME "GLUCOSE FLUID". THE CUSTOMER'S DAUGHTERS REPORTED THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY. NO FURTHER THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER ALSO REPORTEDLY ATE FOOD AND DRANK JUICE TO COUNTERACT THE EVENT. DURING THE TROUBLESHOOTING SURVEY, ADC CUSTOMER SERVICE EDUCATED THE CUSTOMER'S DAUGHTERS ABOUT TEST STRIP COMPATIBILITY AND PLACED AN ORDER TO REPLACE THE PRODUCT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT. A VIAL OF 50 FREESTYLE LITE TEST STRIPS WAS DELIVERED AT THE CUSTOMER'S ADDRESS ON (B)(6) 2010 AT 3:41 PM. ON (B)(6) 2010 ADC CUSTOMER SERVICE PLACED A FOLLOW-UP COURTESY CALL TO THE CUSTOMER AND ADC WAS INFORMED BY THE CUSTOMER'S DAUGHTER THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2010. THEREFORE, THE TYPE OF REPORTABLE EVENT IS CHANGED FROM "SERIOUS INJURY" TO "DEATH". HOWEVER, THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER DETAILS ABOUT THE EVENT WERE PROVIDED. LATER ATTEMPTS TO CONTACT THE CUSTOMER'S RELATIVES WERE MADE, BUT THEY COULD NOT BE REACHED. A FOLLOW-UP REPORT WILL BE PROVIDED IN CASE UPON RECEIPT OF ANY ADDITIONAL INFORMATION RELATED TO THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTED CUSTOMER'S FREESTYLE FREEDOM LITE METER TURNED ON WITH BUTTON PRESSED BUT DID NOT TURN ON WITH TEST STRIP INSERTION. CUSTOMER'S DAUGHTER ALSO INQUIRED ABOUT PURCHASING FREESTYLE CLASSIC TEST STRIPS FOR THEIR FREESTYLE FREEDOM LITE METER. CUSTOMER'S DAUGHTER ALSO REPORTED CUSTOMER LOST CONSCIOUSNESS WHEN SHE WAS ABOUT TO TAKE HER INSULIN MEDICATION AND SHE DID NOT RECALL EXPERIENCING ANY SYMPTOMS AT THE TIME OF HER EVENT. CUSTOMER'S DAUGHTER FURTHER REPORTED CUSTOMER ATE FOOD AND DRANK JUICE TO COUNTERACT HER EVENT. PARAMEDICS WERE CALLED AND THEY TREATED CUSTOMER WITH AN UNSPECIFIED SHOT AND SOME "GLUCOSE FLUID". THERE WAS NO REPORT OF DIAGNOSIS, DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THE DEVICE AREA AND TIGHTNESS IN THE JAWLINE. IT WAS NOTED THAT THE PATIENT HAD THE DEVICE MOVED TO 'ANOTHER POCKET' APPROXIMATELY ONE WEEK PRIOR. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0907006

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R