FREESTYLE LIBRE 14 DAY
Report
- Report Number
- 2954323-2019-07174
- Event Type
- Injury
- Date Received
- September 17, 2019
- Date of Event
- June 19, 2019
- Report Date
- October 24, 2019
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- PZE
- PMA / PMN Number
- P160030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ZA
- 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THIS IS A CORRECTION DOCUMENT FOR DATE RECEIVED BY MFG, THIS SECTION HAS BEEN UPDATED WITH THE CORRECT DATE AS THE INITIAL 30 DAY REPORTED DATE WAS DOCUMENTED INCORRECTLY.
SENSOR (B)(4) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM RETURNED SENSOR USING APPROVED SOFTWARE. SENSOR FOUND TO BE IN STATE 5 (INDICATING NORMAL TERMINATION). THE SENSOR PLUG WAS RETURNED. THE SENSOR PLUG WAS PROPERLY SEATED IN THE MOUNT. REMOVED THE SENSOR PLUG AND INSPECTED THE PLUG ASSEMBLY, NO ISSUES WERE OBSERVED. SENSOR WAS REPROGRAMMED AND CURRENT WAS APPLIED TO PERFORM LINEARITY TESTING WHILE IN THE TEST FIXTURE. ALL RESULTS WERE WITHIN SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. THE DEVICE MFG. DATE 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 THIS IS A CORRECTION DOCUMENT. THE INVESTIGATIONAL RESULTS OMITTED FROM THE CORRECTIONAL REPORT.
A CUSTOMER REPORTED A HIGH READINGS ISSUE WITH THE ADC FREESTYLE LIBRE SENSOR USING FREESTYLE LIBRELINK ON THEIR (B)(6) TO SCAN. ON (B)(6) 2019, THE CUSTOMER SELF-TREATED WITH INSULIN(DOSE UNKNOWN) BASED ON THE UNSPECIFIED HIGH SENSOR SCAN RESULT WITHOUT CONFIRMING BY BLOOD TEST, AND SUBSEQUENTLY BECAME "SWEATY AND ICE COLD". THE CUSTOMER'S HUSBAND CALLED PARAMEDICS WHO TREATED THE CUSTOMER WITH GLUCOSE AND FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED A HIGH READINGS ISSUE WITH THE ADC FREESTYLE LIBRE SENSOR USING FREESTYLE LIBRELINK ON THEIR IPHONE-X PLUS-1241-2211055 TO SCAN. ON (B)(6) 2019 THE CUSTOMER SELF-TREATED WITH INSULIN(DOSE UNKNOWN) BASED ON THE UNSPECIFIED HIGH SENSOR SCAN RESULT WITHOUT CONFIRMING BY BLOOD TEST, AND SUBSEQUENTLY BECAME "SWEATY AND ICE COLD". THE CUSTOMER'S HUSBAND CALLED PARAMEDICS WHO TREATED THE CUSTOMER WITH GLUCOSE AND FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A CUSTOMER REPORTED A HIGH READINGS ISSUE WITH THE ADC FREESTYLE LIBRE SENSOR USING FREESTYLE LIBRELINK ON THEIR (B)(6) TO SCAN. ON (B)(6) 2019, THE CUSTOMER SELF-TREATED WITH INSULIN(DOSE UNKNOWN) BASED ON THE UNSPECIFIED HIGH SENSOR SCAN RESULT WITHOUT CONFIRMING BY BLOOD TEST, AND SUBSEQUENTLY BECAME "SWEATY AND ICE COLD". THE CUSTOMER'S HUSBAND CALLED PARAMEDICS WHO TREATED THE CUSTOMER WITH GLUCOSE AND FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 868519 | FREESTYLE LIBRE 14 DAY | FLASH GLUCOSE MONITORING SYSTEM | PZE | ABBOTT DIABETES CARE INC | 71940-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |