BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2832911 · Received November 14, 2012

    Report

    Report Number
    2954323-2012-06720
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 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

    THE METER WAS RETURNED AND TESTED WITH RETAINED TEST STRIPS OF A DIFFERENT LOT. 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 NOT FOUND IN METER MEMORY. REQUESTED TEST STRIPS WERE NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1265118) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2012 AT 9:58 AM HE RECEIVED A READING OF 160 MG/DL ON HIS ADC BLOOD GLUCOSE METER, WHICH WAS LOWER THAN HE FELT. HE FURTHER REPORTED THAT HE WAS FEELING "VERY SICK", WAS "VOMITING" AND THEN EXPERIENCED A LOSS OF CONSCIOUSNESS. CUSTOMER SELF-TREATED WITH AN UNSPECIFIED MEDICATION AND THEN WAS "RUSHED TO THE HOSPITAL", (CUSTOMER DENIED PARAMEDIC INVOLVEMENT). AT THE HOSPITAL A READING OF 804 MG/DL WAS RECEIVED AT 10:15 AM. CUSTOMER WAS TREATED WITH AN UNSPECIFIED AMOUNT OF INSULIN. NO DIAGNOSIS WAS AVAILABLE BECAUSE HIS LABORATORY RESULTS WERE STILL PENDING. 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 1265118

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R