BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2834565 · Received November 15, 2012

    Report

    Report Number
    2954323-2012-06721
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 20, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1180024) 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 PRODUCT 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. A SIMILAR READING TO THE 445 MG/DL THE CUSTOMER REPORTED WAS FOUND IN THE METER'S MEMORY.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THAT ON (B)(6) 2012, PRIOR TO GOING TO SLEEP, CUSTOMER TESTED ON HIS ADC BLOOD GLUCOSE METER AND RECEIVED A READING OF 445 MG/DL, WHICH WAS LOWER THAN A READING OF 985 MG/DL RECEIVED BY A HEALTHCARE PROFESSIONAL THE NEXT DAY. CUSTOMER WAS GIVEN AN UNKNOWN AMOUNT OF INSULIN IN RESPONSE TO THE READING. THE NEXT MORNING, (B)(6) 2012, CUSTOMER WAS FOUND UNRESPONSIVE, HAVING EXPERIENCED A LOSS OF CONSCIOUSNESS, AND PARAMEDICS WERE CALLED. CUSTOMER WAS TRANSPORTED TO A LOCAL HEALTHCARE FACILITY, WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA AND DKA (DIABETIC KETOACIDOSIS), TRANSFERRED TO THE INTENSIVE CARE UNIT AND TREATED WITH INSULIN VIA INTRAVENOUS INFUSION. CUSTOMER'S WIFE WAS CONTACTED IN FOLLOW-UP AND IT WAS REVEALED THE CUSTOMER HAD SUSTAINED A "HEART ATTACK" AND WAS CURRENTLY "IN A SUGAR COMA AND WAS INCONTINENT BECAUSE OF THE METER". SHE ALSO NOTED THAT ON (B)(6) 2012 "A READING OF 240 MG/DL WAS RECEIVED ON THE METER, BUT IT WAS ACTUALLY 874 MG/DL" (IT IS UNKNOWN HOW THIS INFORMATION WAS DETERMINED). CALLER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1180024

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R