BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2964349 · Received February 15, 2013

    Report

    Report Number
    2954323-2013-00100
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1262332) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. 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 REPORTED READING WAS NOT FOUND IN THE METER'S MEMORY.

    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.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S MOTHER) REPORTED THAT SHE USED HER SON'S ADC METER TO TEST HIS BLOOD GLUCOSE LEVEL WHILE HE WAS SLEEPING AND OBTAINED A READING OF 123 MG/DL, WHICH WAS HIGHER THAT SHE BELIEVED THE METER SHOULD READ. CALLER FURTHER REPORTED THAT HER SON WAS "UNRESPONSIVE AND STIFF". SHE REPORTED HER SON WAS "IN A BIG SUGAR LOW DOWN" AND THAT THE METER SHOULD READ "40 OR LOWER" WHICH IS "WHAT HAPPENS WHEN HE HAS A LOW BLOOD SUGAR SEIZURE". AS A RESULT OF GETTING A HIGHER THAN EXPECTED READING, CUSTOMER'S MOTHER STATED SHE IS "TRYING TO GET HIM (HER SON) TO DRINK ENSURE", WHICH IS ABOUT 8 OZ AND HAS 50 GRAMS OF CARBS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED; CUSTOMER'S MOTHER STATED THAT SHE "HAS NOT CALLED THE PARAMEDICS YET". 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
    68111 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1262332

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other