FREESTYLE LIBRE 14 DAY
Report
- Report Number
- 2954323-2022-07833
- Event Type
- Injury
- Date Received
- March 9, 2022
- Date of Event
- February 28, 2022
- Report Date
- May 16, 2023
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- PZE
- PMA / PMN Number
- P160030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- 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. 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. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE SENSOR AND SENSOR KIT 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.
SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). INSPECTED THE PLUG ASSEMBLY. VISUAL INSPECTION WAS PERFORMED AND OBSERVED DEBRIS THAT APPEAR TO BE FLAKES OF MATERIAL ON PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) TRIANGLE. THE CURRENT WAS APPLIED TO THE SENSOR TO PERFORM ACCURACY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. THE DEBRIS WAS OBSERVED ON THE SENSOR PLUG BEING REMOVED DURING PRODUCT RETURN INVESTIGATION AS THE DEBRIS MAY HAVE DISLODGED FROM THE SENSOR PLUG OR SENSOR HOUSING AND LANDED IN THE PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) TRIANGLE INDICATING IT WAS NOT PRESENT PRIOR TO ITS REMOVAL. IN ADDITION, THE PASSING OF ALL TESTS DURING THE INVESTIGATION INDICATES THAT THE DEBRIS THAT IS PRESENT IS NOT SUFFICIENT AND DID NOT IMPACT THE SENSOR¿S ABILITY TO GENERATE AN ACCURATE GLUCOSE READING. THEREFORE, ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A LOW READING ISSUE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER RECEIVED LOWER SCAN RESULTS COMPARED TO READINGS OBTAINED ON A COMPETITOR BRAND METER AND EXPERIENCED SYMPTOMS DESCRIBED AS DIZZINESS, HEADACHE, VOMITING, AND FATIGUE. CUSTOMER WAS SEEN AT A HEALTH CLINIC WHERE SHE WAS TREATED WITH INTRAVENOUS FLUIDS AND NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
A LOW READING ISSUE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER RECEIVED LOWER SCAN RESULTS COMPARED TO READINGS OBTAINED ON A COMPETITOR BRAND METER AND EXPERIENCED SYMPTOMS DESCRIBED AS DIZZINESS, HEADACHE, VOMITING, AND FATIGUE. CUSTOMER WAS SEEN AT A HEALTH CLINIC WHERE SHE WAS TREATED WITH INTRAVENOUS FLUIDS AND NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
A LOW READING ISSUE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER RECEIVED LOWER SCAN RESULTS COMPARED TO READINGS OBTAINED ON A COMPETITOR BRAND METER AND EXPERIENCED SYMPTOMS DESCRIBED AS DIZZINESS, HEADACHE, VOMITING, AND FATIGUE. CUSTOMER WAS SEEN AT A HEALTH CLINIC WHERE SHE WAS TREATED WITH INTRAVENOUS FLUIDS AND NO FURTHER TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2759729 | FREESTYLE LIBRE 14 DAY | FLASH GLUCOSE MONITORING SYSTEM | PZE | ABBOTT DIABETES CARE INC | 71940-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |