FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2022-05925
- Event Type
- Injury
- Date Received
- February 21, 2022
- Date of Event
- February 3, 2022
- Report Date
- March 24, 2022
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QBJ
- PMA / PMN Number
- VERIFY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
ADDITIONAL INFORMATION: SECTION D7 (EXPIRATION DATE) AND H4 (DEVICE MFG DATE) WERE UPDATED BASED ON RETURNED PRODUCT DOWNLOAD. SENSOR 068ZJFK0K HAS BEEN RETURNED AND INVESTIGATED. NO PHYSICAL DAMAGE WAS OBSERVED ON THE RETURNED SENSOR PATCH AND NO ISSUES WERE OBSERVED WITH THE RETURNED SENSOR ADHESIVE. NO MALFUNCTION OR PRODUCT DEFICIENCY HAS BEEN IDENTIFIED. AN EXTENDED INVESTIGATION WAS ALSO PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATIONS. THE REPORTED COMPLAINT IS RELATED TO SKIN IRRITATION OR AN ALLERGIC REACTION TO THE PATCH ADHESIVE OF THE FREESTYLE LIBRE SENSOR. DHRS (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. SHELF-LIFE STUDIES AND PRODUCT MONITORING & DOSE AUDITS WERE PERFORMED DURING PRODUCT DEVELOPMENT AND ON-MARKET PERFORMANCE CONTINUES TO BE MONITORED VIA PRODUCT MONITORING/DOSE AUDITS AS A PART OF ON MARKET PERFORMANCE MONITORING PROCESS. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, MODEL NUMBER 72114-01 WHICH HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., MODEL NUMBER 71992-01. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THIS SERVES AS A CORRECTION REPORT. SECTION D1 WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS INITIAL MDR REPORT. THIS SECTION HAVE BEEN UPDATED.
A CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING THE ADC FREESTYLE LIBRE 3 SENSOR, WITH SYMPTOMS OF SWELLING, REDNESS, PAIN, AND INSERTION SITE INFECTION. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL AND RECEIVED UNSPECIFIED TREATMENT FOR THE REPORTED ISSUE AND NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING THE ADC FREESTYLE LIBRE 3 SENSOR, WITH SYMPTOMS OF SWELLING, REDNESS, PAIN, AND INSERTION SITE INFECTION. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL AND RECEIVED UNSPECIFIED TREATMENT FOR THE REPORTED ISSUE AND NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING THE ADC FREESTYLE LIBRE 3 SENSOR, WITH SYMPTOMS OF SWELLING, REDNESS, PAIN, AND INSERTION SITE INFECTION. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL AND RECEIVED UNSPECIFIED TREATMENT FOR THE REPORTED ISSUE AND NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED EXPERIENCING A SKIN REACTION WHILE WEARING THE ADC FREESTYLE LIBRE 3 SENSOR, WITH SYMPTOMS OF SWELLING, REDNESS, PAIN, AND INSERTION SITE INFECTION. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL AND RECEIVED UNSPECIFIED TREATMENT FOR THE REPORTED ISSUE AND NO FURTHER INFORMATION WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820579 | FREESTYLE LIBRE 3 | FLASH GLUCOSE MONITORING SYSTEM | QBJ | ABBOTT DIABETES CARE LTD | 72114-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |