BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 4251006 · Received November 14, 2014

    Report

    Report Number
    2954323-2014-01112
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE CUSTOMER'S METER HAS BEEN RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER AND RETAINED TEST STRIPS (LOT NO: 1456937) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. METER DID POWER ON WITH BUTTON DEPRESSION. METER DID POWER ON WITH STRIP INSERTION. POWER ISSUE IS NOT OBSERVED. ADDITIONALLY, ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. NOTE: THE DATE OF EVENT IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS ADC BLOOD GLUCOSE METER HAD A BLANK SCREEN ISSUE, NOTING THAT SOMETIMES THE METER WOULD TURN ON WITH BUTTON PRESS AND TEST STRIP INSERTION, AND SOMETIMES IT WOULD NOT. CUSTOMER FURTHER REPORTED THAT ON AN UNSPECIFIED DATE/TIME HE COULD NOT TEST SO HE CALLED THE PARAMEDICS. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY WHERE IT WAS NOTED HIS GLUCOSE WAS HIGH AND HE WAS TREATED WITH INSULIN. CUSTOMER ALSO NOTED HE WAS NOT ALLOWED TO EAT FOR TEN HOURS BUT HE DID NOT KNOW WHY. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER AS HE DECLINED TO CONTINUE TROUBLESHOOTING. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736290 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 1457508

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R