BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 8621580 · Received May 17, 2019

    Report

    Report Number
    2954323-2019-04017
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 27, 2019
    Report Date
    August 23, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    UDI-DI
    00357599001018
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION.  DHRS (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. ALL REVIEW ACTIVITIES CONDUCTED ABOVE, INCLUDING BUT NOT LIMITED TO THE FINAL RELEASE TESTING SPECIFICALLY ASSOCIATED WITH THE MANUFACTURE OF THIS PRODUCT, ARE SUFFICIENT INFORMATION IN ORDER TO SHOW IF THE PRODUCT HAS MET SPECIFICATIONS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED, AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT HE COULD NOT RECEIVE SENSOR SCAN READINGS ON HIS ADC FREESTYLE LIBRE, DUE TO A "REPLACE SENSOR" ERROR MESSAGE THAT DISPLAYED ON HIS 8TH DAY OF SENSOR WEAR. THE CALLER INDICATED THAT HE SUBSEQUENTLY EXPERIENCED A SEIZURE AND LOSS OF CONSCIOUSNESS. A PARAMEDIC WAS CALLED, WHO DIAGNOSED THE CUSTOMER WITH HYPOGLYCEMIA AND ADMINISTERED DEXTROSE INJECTION FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT HE COULD NOT RECEIVE SENSOR SCAN READINGS ON HIS ADC FREESTYLE LIBRE, DUE TO A "REPLACE SENSOR" ERROR MESSAGE THAT DISPLAYED ON HIS 8TH DAY OF SENSOR WEAR. THE CALLER INDICATED THAT HE SUBSEQUENTLY EXPERIENCED A SEIZURE AND LOSS OF CONSCIOUSNESS. A PARAMEDIC WAS CALLED, WHO DIAGNOSED THE CUSTOMER WITH HYPOGLYCEMIA AND ADMINISTERED DEXTROSE INJECTION FOR 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
    414475 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71940-01 00357599001018

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention