FREESTYLE LIBRE 14 DAY
Report
- Report Number
- 2954323-2022-07622
- Event Type
- Injury
- Date Received
- March 8, 2022
- Date of Event
- February 23, 2022
- Report Date
- November 8, 2022
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- PZE
- PMA / PMN Number
- P160030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED ON THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATIONS. DHRS FOR THE LIBRE READER WAS REVIEWED AND THE DHRS SHOWED LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. DHRS FOR THE PRECISION STRIPS WERE 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 THE SPECIFICATION AND PASSED. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED, AND A PHYSICAL INVESTIGATION WILL BE PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE REPORTED METER (B)(6) WAS RETURNED AND INVESTIGATED. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED METER AND NO ISSUES WERE OBSERVED. CONTROL SOLUTION TESTING HAS BEEN PERFORMED WITH THE RETAIN STRIPS AND ALL RESULTS WERE SATISFACTORY. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. THEREFORE, THE ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A TESTING ISSUE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER REPORTED THE TEST DID NOT START AFTER THE BLOOD SAMPLE WAS APPLIED AND HE WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED TREMORS, CONFUSION, BLURRED VISION, RESPIRATORY DIFFICULTIES AND WAS UNABLE TO SELF-TREAT. CUSTOMER FURTHER REPORTED RECEIVING THIRD-PARTY INTERVENTION WHO PROVIDED FOOD AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A TESTING ISSUE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER REPORTED THE TEST DID NOT START AFTER THE BLOOD SAMPLE WAS APPLIED AND HE WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED TREMORS, CONFUSION, BLURRED VISION, RESPIRATORY DIFFICULTIES AND WAS UNABLE TO SELF-TREAT. CUSTOMER FURTHER REPORTED RECEIVING THIRD-PARTY INTERVENTION WHO PROVIDED FOOD AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A TESTING ISSUE WAS REPORTED WITH THE ADC DEVICE. CUSTOMER REPORTED THE TEST DID NOT START AFTER THE BLOOD SAMPLE WAS APPLIED AND HE WAS UNABLE TO OBTAIN READINGS. AS A RESULT, CUSTOMER EXPERIENCED TREMORS, CONFUSION, BLURRED VISION, RESPIRATORY DIFFICULTIES AND WAS UNABLE TO SELF-TREAT. CUSTOMER FURTHER REPORTED RECEIVING THIRD-PARTY INTERVENTION WHO PROVIDED FOOD AS TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1325756 | FREESTYLE LIBRE 14 DAY | FLASH GLUCOSE MONITORING SYSTEM | PZE | ABBOTT DIABETES CARE INC | 71940-01 | 4500184835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |