BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 8259380 · Received January 17, 2019

    Report

    Report Number
    2954323-2019-00531
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 24, 2018
    Report Date
    March 6, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (DEVICE MFG DATE) HAS BEEN UPDATED BASED ON THE RETURNED PRODUCT DOWNLOAD. SENSOR (B)(4) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM RETURNED SENSOR USING APPROVED SOFTWARE. SENSOR FOUND TO BE IN STATE 5 (INDICATING NORMAL TERMINATION). THE SENSOR PLUG WAS PROPERLY SEATED IN THE MOUNT. REMOVED THE SENSOR PLUG AND INSPECTED THE PLUG ASSEMBLY, NO FAILURE MODE OBSERVED. SENSOR WAS REPROGRAMMED AND CURRENT WAS APPLIED TO PERFORM LINEARITY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    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 DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A HIGH READINGS ISSUE WITH THE ADC FREESTYLE LIBRE. THE CUSTOMER REPORTED RECEIVING SENSOR SCAN RESULTS OF 14.6 MMOL/L, 13.00 MMOL/L, 16.00 MMOL/L, 11.00 MMOL/L, AND 12.00 MMOL/L, AND RESPECTIVE BUILT-IN METER READINGS OF 11.60 MMOL/L, 11.00 MMOL/L, 14.00 MMOL/L, 8.00 MMOL/L, AND 10 MMOL/L. THE CUSTOMER FURTHER REPORTED BEING A "LITTLE SHAKY" AND EXPERIENCING A LOSS OF CONSCIOUSNESS. A GLUCOSE INJECTION WAS ADMINISTERED BY THE CUSTOMER'S WIFE. NO FURTHER TREATMENT OR INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A HIGH READINGS ISSUE WITH THE ADC FREESTYLE LIBRE. THE CUSTOMER REPORTED RECEIVING SENSOR SCAN RESULTS OF 14.6 MMOL/L, 13.00 MMOL/L, 16.00 MMOL/L, 11.00 MMOL/L, AND 12.00 MMOL/L, AND RESPECTIVE BUILT-IN METER READINGS OF 11.60 MMOL/L, 11.00 MMOL/L, 14.00 MMOL/L, 8.00 MMOL/L, AND 10 MMOL/L. THE CUSTOMER FURTHER REPORTED BEING A "LITTLE SHAKY" AND EXPERIENCING A LOSS OF CONSCIOUSNESS. A GLUCOSE INJECTION WAS ADMINISTERED BY THE CUSTOMER'S WIFE. NO FURTHER TREATMENT OR INTERVENTION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51282 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention