MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-25 for FREESTYLE LIBRE 14 DAY 71940-01 manufactured by Abbott Diabetes Care Inc.
[185904788]
The reported product is not expected to be returned as reporter indicated she no longer has the equipment. A follow-up report will be filed if product is returned or 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.
Patient Sequence No: 1, Text Type: N, H10
[185904789]
A high readings issue was reported with the freestyle libre sensor. Customer reported being at the hospital for an issue unrelated to the use of the device when she experienced symptoms described as weakness, cold sweats, tremors, and palpitations. Customer obtained a sensor scan result of 93 mg/dl compared to a reading of 48 mg/dl obtained on the hcp meter. A nurse treated the customer with g30 glucose and customer was cleared to go home. Upon arriving home an hour later, customer experienced the same symptoms and obtained a sensor scan result of 95 mg/dl compared to a reading of 42 mg/dl obtained on an unspecified blood glucose device. Customer was treated by her husband with "sugars and sweets". No further treatment was reported. There was no report of death or permanent injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-02310 |
| MDR Report Key | 9878811 |
| Report Source | CONSUMER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2020-03-20 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Model Number | 71940-01 |
| 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 | 2020-03-25 |