FREESTYLE LIBRE
Report
- Report Number
- 2954323-2021-93413
- Event Type
- Malfunction
- Date Received
- November 23, 2021
- Date of Event
- November 2, 2021
- Report Date
- November 8, 2022
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- PZE
- PMA / PMN Number
- P160030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 003
Narratives
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. DHR FOR THE LIBRE READER WERE REVIEWED AND THE DHR SHOWED THE LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. DHRS FOR THE PRECISION STRIPS WAS REVIEWED AND THE DHRS SHOWED THE PRECISION STRIPS PASSED ALL TESTS PRIOR TO RELEASE. RETAIN TESTING WAS PERFORMED FOR PRECISION STRIPS AND ALL UNITS PERFORMED IN SPECIFICATION AND PASSED. 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. THIS IS A CORRECTION TO THE REPORT EMDR-222681. THE DEVICE HISTORY REVIEW FOR PRECISION STRIPS, SECTION H10 (ADDTL MFG NARRATIVE), WAS LEFT OUT OF THE EMDR-222681 REPORT.
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. DHR FOR THE LIBRE READER WERE REVIEWED AND THE DHR SHOWED THE LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. DHRS FOR THE PRECISION STRIPS WAS REVIEWED AND THE DHRS SHOWED THE PRECISION STRIPS PASSED ALL TESTS PRIOR TO RELEASE. RETAIN TESTING WAS PERFORMED FOR PRECISION STRIPS AND ALL UNITS PERFORMED IN SPECIFICATION AND PASSED. 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.THIS SERVES AS A CORRECTION REPORT. SECTION G-3 ( DATE RECEIVED BY MFG) WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS FOLLOW UP #3 REPORT. THE CORRECT G-3 DATE WAS OCT 10, 2022.
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. DHR FOR THE LIBRE READER WERE REVIEWED AND THE DHR SHOWED THE LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. 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. RETAIN TESTING WAS PERFORMED FOR PRECISION STRIPS AND ALL UNITS PERFORMED IN SPECIFICATION AND PASSED. 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.THIS SERVES AS A CORRECTION REPORT. SECTION H4 - DEVICE MFG DATE WAS INCORRECTLY DOCUMENTED IN THE INITIAL MDR SUBMISSION. THE SECTIONH4 - DEVICE MFG DATE HAS BEEN CORRECTLY UPDATED.
THE REPORTED READER HAS BEEN RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. VISUALLY INSPECTED THE READER AND NO ISSUES WERE OBSERVED. CONTROL SOLUTION TESTING HAS BEEN PERFORMED AND ALL RESULTS WERE WITHIN RANGE SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
NO PRODUCT HAS BEEN RETURNED, EXTENDED INVESTIGATION IS PENDING AT THIS TIME. A FOLLOW- UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MANUFACTURER DATE FOR THE REPORTED READER IS UNKNOWN. THE DATE ENTERED IN IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC FREESTYLE LIBRE BUILT IN METER. CUSTOMER REPORTED RECEIVING READINGS OF 106 MG/DL, 424 MG/DL, 370 MG/DL AND 87 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC FREESTYLE LIBRE BUILT IN METER. CUSTOMER REPORTED RECEIVING READINGS OF 106 MG/DL, 424 MG/DL, 370 MG/DL AND 87 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC FREESTYLE LIBRE BUILT IN METER. CUSTOMER REPORTED RECEIVING READINGS OF 106 MG/DL, 424 MG/DL, 370 MG/DL AND 87 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC FREESTYLE LIBRE BUILT IN METER. CUSTOMER REPORTED RECEIVING READINGS OF 106 MG/DL, 424 MG/DL, 370 MG/DL AND 87 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC FREESTYLE LIBRE BUILT IN METER. CUSTOMER REPORTED RECEIVING READINGS OF 106 MG/DL, 424 MG/DL, 370 MG/DL AND 87 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1764407 | FREESTYLE LIBRE | FLASH GLUCOSE MONITORING SYSTEM | PZE | ABBOTT DIABETES CARE INC | 71938-01 | 4500184787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |