BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LANCING DEVICE II

    MDR report key: 11653865 · Received April 12, 2021

    Report

    Report Number
    2954323-2021-66193
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 12, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    FMK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND LANCING DEVICE, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FIRING MECHANISM ON HIS ADC LANCING DEVICE WAS NOT WORKING AND HE WAS THEREFORE UNABLE TO CHECK HIS BLOOD GLUCOSE. CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS "THIRSTY, WEAK AND BODY FEELING HOT" AND WAS UNABLE TO SELF-TREAT. CUSTOMER WAS SEEN AT THE HOSPITAL WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA AND RECEIVED UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551024 FREESTYLE LANCING DEVICE II LANCING DEVICE FMK ABBOTT DIABETES CARE INC 71582-01

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention