BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1862614 · Received October 8, 2010

    Report

    Report Number
    2954323-2010-01407
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 16, 2010
    Report Date
    January 5, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. IN ADDITION, THE TEST STRIPS WERE NOT RETURNED. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (B)(6) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: DURING THE TROUBLESHOOTING SURVEY, IT WAS ADDITIONALLY REPORTED THAT THE CUSTOMER DID NOT WASH THE TEST SITE PRIOR TO TESTING AND ADC CUSTOMER SERVICE EDUCATED THE CUSTOMER'S WIFE THAT THE CUSTOMER SHOULD WASH AND DRY THE TEST SITE BEFORE TESTING.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN N-HANCE ROD, IMPLANTED ON AN UNK DATE WAS NOTED A BROKEN ON X-RAYS. SURGEON HAS NO PLANS FOR REMOVAL AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, UPON INTERROGATION OF THE ICD INVOLVED IN THIS MDR, THE FOLLOWING ALERT MESSAGE WAS NOTED AGAIN: "LAST RESET DATE 18 FEB 2010. THE DEVICE WAS REINITIALIZED 1 TIME SINCE BEGINNING OF LIFE". THIS MESSAGE WAS FIRST NOTED (B)(6) 2010. FILES WERE RETRIEVED FROM THE (B)(6) 2010 CHECK AS DATA EXPORT PROBLEMS OCCURRED ON THE PROGRAMMER HOLDING THE OTHER F/U CHECKS.

    Description of Event or Problem · 1

    THE CUSTOMER'S WIFE REPORTED THAT ON (B)(6) 2010 THE CUSTOMER DID NOT FEEL WELL. THE CUSTOMER REPORTEDLY OBTAINED READINGS ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER WHICH "DID NOT MATCH THE WAY HE FELT". THE CUSTOMER'S WIFE ALSO REPORTED THE CUSTOMER EXPERIENCED WEAKNESS AND THE PARAMEDICS WERE CALLED. THE CUSTOMER REPORTEDLY COMPARED A READING OF 174 MG/DL OBTAINED ON HIS ADC METER TO A READING OF 31 MG/DL RECEIVED ON AN UNSPECIFIED HEALTH CARE PROVIDER DEVICE. IT WAS FURTHER REPORTED THE CUSTOMER WAS TREATED BY THE PARAMEDICS WITH AN INTRAVENOUS SOLUTION MEDICATION AND SUGAR FROSTING. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0935201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention