BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 6126506 · Received November 23, 2016

    Report

    Report Number
    2954323-2016-07145
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    November 1, 2016
    Report Date
    October 16, 2017
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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 RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Additional Manufacturer Narrative · 1

    GIVEN NO TEST STRIPS WERE RETURNED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER ((B)(4)) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S PRODUCTS HAVE BEEN REQUESTED FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HER ADC BLOOD GLUCOSE METER. READINGS WERE REPORTED AS FOLLOWS FROM (B)(6) 2016: 35 MG/DL AT 4:21 AM; 108 MG/DL AT 4:36 AM; 51 MG/DL AT 4:42 AM. THE CUSTOMER REPORTED THAT ON (B)(6) AROUND 8:30-9:30 AM, SHE FELT ¿GOOFY AND FUNNY¿. CUSTOMER SELF-TREATED WITH A GLASS OF WATER WITH HONEY TO RAISE HER BLOOD GLUCOSE. PARAMEDICS WERE CALLED AND ADMINISTERED A GLUCAGON INJECTION. THE CUSTOMER DID NOT KNOW WHAT READINGS WERE OBTAINED BY THE PARAMEDICS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HER ADC BLOOD GLUCOSE METER. READINGS WERE REPORTED AS FOLLOWS FROM (B)(6) 2016: 35 MG/DL AT 4:21 AM; 108 MG/DL AT 4:36 AM; 51 MG/DL AT 4:42 AM. THE CUSTOMER REPORTED THAT ON (B)(6) AROUND 8:30-9:30 AM, SHE FELT ¿GOOFY AND FUNNY¿. CUSTOMER SELF-TREATED WITH A GLASS OF WATER WITH HONEY TO RAISE HER BLOOD GLUCOSE. PARAMEDICS WERE CALLED AND ADMINISTERED A GLUCAGON INJECTION. THE CUSTOMER DID NOT KNOW WHAT READINGS WERE OBTAINED BY THE PARAMEDICS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777303 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 71501-01 1611721

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention