BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7141169 · Received December 21, 2017

    Report

    Report Number
    2954323-2017-09038
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    November 25, 2017
    Report Date
    February 8, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    003

    Narratives

    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 (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 THAT 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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE METER IS RETURNED OR ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF MANUFACTURE IS UNKNOWN. NOTE: THAT THERE WAS NO INDICATION THAT THE BUILT-IN METER OF THE CUSTOMER'S FREESTYLE LIBRE READER WAS NOT FUNCTIONING AT THE TIME OF THE REPORTED EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DELIVERY ISSUE INVOLVING A REPLACEMENT SENSOR. CUSTOMER INITIALLY CALLED ADC CUSTOMER SERVICES ON (B)(6) 2017 TO REPORT A ¿REPLACE SENSOR MESSAGE¿. CUSTOMER CALLED AGAIN ON (B)(6) 2017 TO REPORT THAT BECAUSE SHE NEVER RECEIVED THE REPLACEMENT SENSOR SHE WAS UNABLE TO USE THE ADC LIBRE SENSOR TO MONITOR HER GLUCOSE. SHE FURTHER REPORTED THAT ON (B)(6) 2017 SHE WAS EXPERIENCING ¿DIZZINESS, A FEVER AND WAS FEELING BAD¿ SO SHE SELF-PRESENTED TO A HOSPITAL. AT THE HOSPITAL, CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA, DUE TO UNSPECIFIED ¿HIGH GLUCOSE¿, AND WAS TREATED WITH AN UNSPECIFIED AMOUNT OF INSULIN. NO ADDITIONAL TREATMENT WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DELIVERY ISSUE INVOLVING A REPLACEMENT SENSOR. CUSTOMER INITIALLY CALLED ADC CUSTOMER SERVICES ON (B)(6) 2017 TO REPORT A ¿REPLACE SENSOR MESSAGE¿. CUSTOMER CALLED AGAIN ON (B)(6) 2017 TO REPORT THAT BECAUSE SHE NEVER RECEIVED THE REPLACEMENT SENSOR SHE WAS UNABLE TO USE THE ADC LIBRE SENSOR TO MONITOR HER GLUCOSE. SHE FURTHER REPORTED THAT ON (B)(6) 2017 SHE WAS EXPERIENCING ¿DIZZINESS, A FEVER AND WAS FEELING BAD¿ SO SHE SELF-PRESENTED TO A HOSPITAL. AT THE HOSPITAL, CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA, DUE TO UNSPECIFIED ¿HIGH GLUCOSE¿, AND WAS TREATED WITH AN UNSPECIFIED AMOUNT OF INSULIN. NO ADDITIONAL TREATMENT WAS REQUIRED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919266 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention