MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-27 for FREESTYLE LIBRE 14 DAY 71940-01 manufactured by Abbott Diabetes Care Inc.
[185695552]
The product has been requested back for an investigation and not expected to be returned. A follow-up report will be submitted once additional information is obtained. The date of event is unknown. The date entered is the date abbott diabetes care became aware of the event. 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.
Patient Sequence No: 1, Text Type: N, H10
[185695553]
Abbott diabetes care received a user report from the health and youth care inspectorate which reported the following information: a customer experienced skin reaction while wearing adc freestyle libre sensor. Customer experienced "local swelling, localized erythema and flu like symptoms" following the wear of sensor and the swelling and erythema increased like a developing abscess/cellulitis. An ultrasound of the upper arm was performed that showed infiltrated fat tissue with no evidence of abscess and no foreign body inside. It was additionally reported that there was no increase in the parameters of infection. Customer was treated with flucloxacillin. The customer had not recovered from flu like symptoms, local swelling and localized erythema 2 days after onset. There was no report of death or permanent injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-02346 |
| MDR Report Key | 9891448 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-03-27 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2020-03-19 |
| Date Added to Maude | 2020-03-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2020-03-27 |
| Model Number | 71940-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-27 |