MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for FREESTYLE LIBRE manufactured by Abbott Diabetes Care Inc..
[116733465]
Purchased the freestyle libre on (b)(6) 2018 and inserted the sensor at 2:14 pm. All readings obtained via the sensor were consistently lower at least 80-90 mg/dl than the actual finger stick value. The last glucose obtained via sensor was 201 and the finger stick result was 350 mg/dl. My daughter was nauseous and was complaining of abdominal pain. The 350 mg/dl glucose was corrected via her insulin pump. I began to search online for any complaints or issues with this device and there were many complaining of the sensor reporting low glucose when they were actually high. Sensor sn: (b)(4), reader sn: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078950 |
| MDR Report Key | 7768319 |
| Date Received | 2018-08-08 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-08-07 |
| Date Added to Maude | 2018-08-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FREESTYLE LIBRE |
| Generic Name | CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA |
| Product Code | PHV |
| Date Received | 2018-08-08 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETES CARE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-08 |