MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-26 for FREESTYLE LIBRE 14 DAY 71940-01 71940 manufactured by Abbott Diabetes Care Inc.
[185146522]
At this time, product has not yet been returned. An extended investigation has been performed for the reported complaint. There was no indication that the product did not meet specification. The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor. Dhrs (device history review) for the freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle libre sensor kit passed all tests prior to release. Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products. Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality. 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.
Patient Sequence No: 1, Text Type: N, H10
[185146523]
The customer reported a skin reaction at the site of the freestyle libre sensor, with symptoms of "allergic reaction" and rash. The customer had contact with a healthcare professional, who provided an unspecified spray as treatment. There was no report of death or permanent injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-02327 |
| MDR Report Key | 9885157 |
| Report Source | CONSUMER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-12-18 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TARA WILLIAMSON |
| Manufacturer Street | 1360 SOUTH LOOP ROAD |
| Manufacturer City | ALAMEDA CA 945027001 |
| Manufacturer Country | US |
| Manufacturer Postal | 945027001 |
| Manufacturer Phone | 5108644472 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREESTYLE LIBRE 14 DAY |
| Generic Name | FLASH GLUCOSE MONITORING SYSTEM |
| Product Code | PZE |
| Date Received | 2020-03-26 |
| Model Number | 71940-01 |
| Catalog Number | 71940 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETES CARE INC |
| Manufacturer Address | 1360 SOUTH LOOP ROAD ALAMEDA CA 945027001 US 945027001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |