BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 3241657 · Received July 22, 2013

    Report

    Report Number
    2954323-2013-00394
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 28, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL/FINAL REPORT. THE METER HAS BEEN RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER AND TEST STRIPS AND RETAINED CONTROL SOLUTION HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. A REVIEW OF THE METER'S INTERNAL MEMORY LOG REVEALED THE DATE/TIME OF THE METER HAD NOT BEEN SET TO THE CORRECT DATE, SO IT IS IMPOSSIBLE TO VERIFY IF THE READINGS WERE OBTAINED AT THE TIME THEY WERE REPORTEDLY RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER (CUSTOMER IS A CHILD) REPORTED THAT ON (B)(6) 2013 AT APPROXIMATELY 4:00 PM. CUSTOMER WAS "SICK", WAS "THROWING UP" AND SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. CUSTOMER WAS GIVEN A "SWEET DRINK" PRIOR TO HER LOSS OF CONSCIOUSNESS. CALLER REPORTED CUSTOMER'S ADC METER HAD PROVIDED A "FALSE HIGH READING" (NOT PROVIDED) EARLIER IN THE DAY AND NOTED SHE HAD GIVEN THE CUSTOMER EXTRA INSULIN AT LUNCHTIME. PARAMEDICS WERE CALLED. UPON ARRIVAL A GLUCOSE TEST COMPARISON WAS DONE BETWEEN CUSTOMER'S ADC BLOOD GLUCOSE METER AND THE PARAMEDIC'S UNKNOWN BRAND OF METER. A READING OF 8.4 MMOL/L (151 MG/DL) WAS RECEIVED ON THE CUSTOMER'S ADC BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN A READING OF 2.4 MMOL/L (43 MG/DL) RECEIVED ON THE PARAMEDIC'S METER, WITHIN 10 MINUTES OF EACH OTHER. AN INTRAVENOUS INFUSION OF GLUCOSE (30%) WAS STARTED AND THE CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH ADDITIONAL INTRAVENOUS FLUIDS AND ORAL GLUCOSE, UPON REGAINING CONSCIOUSNESS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340384 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1352520

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R