BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 13053006 · Received December 21, 2021

    Report

    Report Number
    2954323-2021-96252
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    December 16, 2021
    Report Date
    December 28, 2021
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MANUFACTURING DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. NO PRODUCT HAS 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. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. 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 · 0

    A CUSTOMER REPORTED AN ERROR CODE WITH THE FREESTYLE LIBRE 2 SENSOR, AND WAS THEREFORE UNABLE TO OBTAIN SCAN READINGS. THE CUSTOMER SUBSEQUENTLY EXPERIENCED A SEIZURE AND WAS TAKEN TO A HEALTH CLINIC WHERE SHE RECEIVED TREATMENT OF GLUCOSE INJECTION FROM A HEALTHCARE PROFESSIONAL. THE CUSTOMER WAS ADDITIONALLY GIVEN 400 MG ANTICONVULSANT, VITAMINS, "CALCIUM QUETERAPEN 100", SLEEP TABLET, AND "STOMACH TABLET" MEDICATIONS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED AN ERROR CODE WITH THE FREESTYLE LIBRE 2 SENSOR, AND WAS THEREFORE UNABLE TO OBTAIN SCAN READINGS. THE CUSTOMER SUBSEQUENTLY EXPERIENCED A SEIZURE AND WAS TAKEN TO A HEALTH CLINIC WHERE SHE RECEIVED TREATMENT OF GLUCOSE INJECTION FROM A HEALTHCARE PROFESSIONAL. THE CUSTOMER WAS ADDITIONALLY GIVEN 400 MG ANTICONVULSANT, VITAMINS, "CALCIUM QUETERAPEN 100", SLEEP TABLET, AND "STOMACH TABLET" MEDICATIONS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949809 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention