BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7119316 · Received December 14, 2017

    Report

    Report Number
    2954323-2017-08812
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 21, 2017
    Report Date
    March 26, 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

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE EXACT DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MANUFACTURER DATE FOR THE REPORTED SENSOR 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 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. DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATES THE CONTINUED EFFECTIVENESS OF THE ESTABLISHED STERILIZATION PROCESS FOR LIBRE SENSOR KITS. ENVIRONMENTAL MONITORING REPORTS WERE REVIEWED, INCLUDING BIOBURDEN AND ENDOTOXIN TESTING, AND DEMONSTRATED THAT ALL MONITORING PROCESSES CONTINUE TO MEET ADC MINIMUM REQUIREMENTS FOR PRODUCT QUALITY. 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 · 1

    CUSTOMER REPORTED EXPERIENCING AN INFECTION WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR. CUSTOMER REPORTED AN INFECTION "TWICE THE SIZE OF THE SENSOR" AND HAD CONTACT WITH A HEALTHCARE PROVIDER WHO PRESCRIBED ORAL ANTIBIOTICS FOR TREATMENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXPERIENCING AN INFECTION WHILE WEARING AN ADC FREESTYLE LIBRE SENSOR. CUSTOMER REPORTED AN INFECTION "TWICE THE SIZE OF THE SENSOR" AND HAD CONTACT WITH A HEALTHCARE PROVIDER WHO PRESCRIBED ORAL ANTIBIOTICS FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899281 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention