FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2022-05840
- Event Type
- Injury
- Date Received
- February 21, 2022
- Date of Event
- January 21, 2022
- Report Date
- May 9, 2022
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QLG
- 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.
SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. PERFORMED A VISUAL INSPECTION ON THE RETURNED SENSOR PATCH AND NO ISSUE WAS OBSERVED. SENSOR DATA WAS EXTRACTED AND OBSERVED TO BE RETURNED IN SENSOR STATE 8 (INDICATING ABNORMAL TERMINATION). AN EXTENDED INVESTIGATION WAS ALSO CONDUCTED. PERFORMED A VISUAL INSPECTION ON RETURNED SENSOR AND NO ABNORMALITIES WERE OBSERVED. THE EVENT LOG 11 (ALGORITHM TERMINATED PATCH) AND AN EXTENDED ERROR CODE 32678 (DQ INVALID DATA) WERE OBSERVED, INDICATING THAT THE TERMINATION WAS DUE TO THE OCCURRENCE OF ESA (EARLY SENSOR ATTENUATION) OR LSA (LATE SENSOR ATTENUATION). A REVIEW OF THE CUSTOMER'S HISTORY LOG REVEALED EVIDENCE OF LOW READINGS OVER A PROLONGED PERIOD OF TIME THE LOW GLUCOSE READINGS WERE DETERMINED TO BE THE RESULT OF A PHYSIOLOGICAL ISSUE, AND THE PATCH ALGORITHM TERMINATED THE PATCH DUE TO INDICATIONS OF LSA. THE REPORTED COMPLAINT RELATED TO THE ¿REPLACE SENSOR¿ MESSAGE WAS DUE TO THE SENSOR TERMINATION. NO ABNORMALITIES WERE OBSERVED ON THE RETURNED SENSOR OR ITS DATA, THEREFORE THE COMPLAINT IS NOT CONFIRMED. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. NO PRODUCT HAS BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND LIBRE SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A CUSTOMER REPORTED THE ERROR MESSAGE WHILE A CUSTOMER WAS SCANNING THE ADC FREESTYLE LIBRE 3 SENSOR. AS A RESULT, ON (B)(6) 2022, THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA DESCRIBED AS "MISSING WORDS," CONFUSION, AND HAD A LOSS OF CONSCIOUSNESS. HCP CONTACT WAS MADE, AND THE CUSTOMER WAS PROVIDED INTRAVENOUS GLUCOSE FOR THE TREATMENT OF HYPOGLYCEMIA. NO FURTHER DETAILS REGARDING THE MEDICAL EVENT WERE PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED THE ERROR MESSAGE WHILE A CUSTOMER WAS SCANNING THE ADC FREESTYLE LIBRE 3 SENSOR. AS A RESULT, ON (B)(6) 2022, THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA DESCRIBED AS "MISSING WORDS," CONFUSION, AND HAD A LOSS OF CONSCIOUSNESS. HCP CONTACT WAS MADE, AND THE CUSTOMER WAS PROVIDED INTRAVENOUS GLUCOSE FOR THE TREATMENT OF HYPOGLYCEMIA. NO FURTHER DETAILS REGARDING THE MEDICAL EVENT WERE PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED THE ERROR MESSAGE WHILE A CUSTOMER WAS SCANNING THE ADC FREESTYLE LIBRE 3 SENSOR. AS A RESULT, IN 21JAN2022, THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA DESCRIBED AS "MISSING WORDS," CONFUSION, AND A LOSS OF CONSCIOUSNESS. HCP CONTACT WAS MADE, AND THE CUSTOMER WAS PROVIDED INTRAVENOUS GLUCOSE FOR THE TREATMENT OF HYPOGLYCEMIA. NO FURTHER DETAILS REGARDING THE MEDICAL EVENT WERE PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED THE ERROR MESSAGE WHILE A CUSTOMER WAS SCANNING THE ADC FREESTYLE LIBRE 3 SENSOR. AS A RESULT, ON (B)(6) 2022, THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA DESCRIBED AS "MISSING WORDS," CONFUSION, AND HAD A LOSS OF CONSCIOUSNESS. HCP CONTACT WAS MADE, AND THE CUSTOMER WAS PROVIDED INTRAVENOUS GLUCOSE FOR THE TREATMENT OF HYPOGLYCEMIA. NO FURTHER DETAILS REGARDING THE MEDICAL EVENT WERE PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130035 | FREESTYLE LIBRE 3 | CONTINUOUS GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE LTD | 72114-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |