BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBRE 2 SENSOR FREESTYLE

    MDR report key: 10900716 · Received November 25, 2020

    Report

    Report Number
    2954323-2020-11817
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 8, 2020
    Report Date
    December 22, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MFG 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 · 1

    NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE SENSOR AND SENSOR KIT 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 · 1

    A HIGH READINGS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 2 SENSOR. CUSTOMER REPORTED RECEIVING SENSOR SCAN RESULTS OF 15 MMOL/L (270 MG/DL) TO 15.5 MMOL/L (279 MMOL/L) AND SELF-TREATING WITH INSULIN (DOSE/TYPE UNSPECIFIED). CUSTOMER SUBSEQUENTLY EXPERIENCED COLD SWEATS AND A LOSS OF CONSCIOUSNESS AND CUSTOMER'S HUSBAND OBTAINED READINGS OF 1.2 MMOL/L (22 MG/DL) AND 1.5 MMOL/L (27 MG/DL) ON AN ADC BLOOD GLUCOSE METER. PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL, CUSTOMER WAS ADMINISTERED INTRAVENOUS GLUCOSE AND TRANSPORTED TO A HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND PROVIDED UNSPECIFIED TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A HIGH READINGS ISSUE WAS REPORTED WITH THE FREESTYLE LIBRE 2 SENSOR. CUSTOMER REPORTED RECEIVING SENSOR SCAN RESULTS OF 15 MMOL/L (270 MG/DL) TO 15.5 MMOL/L (279 MMOL/L) AND SELF-TREATING WITH INSULIN (DOSE/TYPE UNSPECIFIED). CUSTOMER SUBSEQUENTLY EXPERIENCED COLD SWEATS AND A LOSS OF CONSCIOUSNESS AND CUSTOMER'S HUSBAND OBTAINED READINGS OF 1.2 MMOL/L (22 MG/DL) AND 1.5 MMOL/L (27 MG/DL) ON AN ADC BLOOD GLUCOSE METER. PARAMEDICS WERE CALLED AND UPON THEIR ARRIVAL, CUSTOMER WAS ADMINISTERED INTRAVENOUS GLUCOSE AND TRANSPORTED TO A HOSPITAL WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA AND PROVIDED 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
    1364681 LIBRE 2 SENSOR FREESTYLE FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention