MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for FREESTYLE LIBRE 71940-01 manufactured by Abbott Diabetes Care Inc.
[186416584]
The product has been requested back for investigation. A follow- up report will be submitted once additional information is obtained. The device manufacturer date for the reported sensor is unknown. The date entered is the date of the event. All pertinent information available to abbott diabetes care has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[186416585]
Customer reported receiving a low reading from their adc freestyle libre sensor. Customer reported a low reading of 77 mg/dl which was lower than lab reading of 314 mg/dl. The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant. There was no report of death, serious injury, or mistreatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954323-2020-02261 |
| MDR Report Key | 9865617 |
| Report Source | CONSUMER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2020-03-10 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Generic Name | FLASH GLUCOSE MONITORING SYSTEM |
| Product Code | PZE |
| Date Received | 2020-03-23 |
| 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 | 2020-03-23 |