MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for FREESTYLE LIBRE 14 DAY 71940-01 manufactured by Abbott Diabetes Care Inc.
[185751002]
The product has been requested back for an investigation. A follow-up report will be submitted once additional information is obtained. The device manufacturing 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
[185751003]
Hold for erika 03. 31the customer reported a high readings issue with the adc freestyle libre sensor. The customer reported receiving unspecified high sensor scan readings, and subsequently experienced seizures while sleeping. An emergency doctor was called, and a blood glucose of less than 2. 2 mmol/l (40. 0 mg/dl) was obtained on a healthcare meter as compared to a sensor scan of 7. 0 mmol/l (126. 0 mg/dl). The customer was diagnosed with hypoglycemia, and treated with glucagen via injection and given "glucosis". There was no report of death or permanent injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-02408 |
| MDR Report Key | 9901237 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2020-03-25 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| 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 | 2020-03-30 |