MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-23 for ABBOTT FREESTYLE LIBRE 14 CONTINUOUS GLUCOSE MONITOR FREESTYLE LIBRE 14 READER & SENS manufactured by Abbott Diabetes Care Inc..
[134303168]
Failure of data recording correlated with manual sensor reads. At 04:10 hours a manual sensor read was performed on (b)(6) 2019. Correlated with this manual sensor read, the sensor failed to make its glucose measurements at 15 mins intervals leaving a data gap for the next 3 hours and 6 mins. This is a reliability problem with the sensor and creates issues of confidence in this device. Multiple data gap problems occur during the 14 day use cycle for a sensor. Other reports for previous sensor failures have been filed. Based on the info i have given in this report, and my 12 previous reports i have determined that this device is unreliable and i have ceased using it. I have had lengthy telephone conversations with abbott personnel. They finally said the issue would be escalated to the next level and that i would be contacted by a person at that level within one or two days from (b)(6) 2019 when that conversation took place. I have not been contacted by anyone and believe abbott is ignoring me and hoping i will give up and go away. I have informed my physician about the reliability of this device and that i have stopped using it and resumed with finger sticks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083344 |
| MDR Report Key | 8274119 |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-21 |
| Date of Event | 2019-01-08 |
| Date Added to Maude | 2019-01-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | ABBOTT FREESTYLE LIBRE 14 CONTINUOUS GLUCOSE MONITOR |
| Generic Name | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
| Product Code | NBW |
| Date Received | 2019-01-23 |
| Model Number | FREESTYLE LIBRE 14 READER & SENS |
| Device Expiration Date | 2019-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIABETES CARE INC. |
| Brand Name | ABBOTT FREESTYLE LIBRE 14 CONTINUOUS GLUCOSE MONITOR |
| Generic Name | CONTINUOUS GLUCOSE MONITOR RETROSPECTIVE DATA ANALYSIS SOFTWARE |
| Product Code | PHV |
| Date Received | 2019-01-23 |
| Model Number | FREESTYLE LIBRE 14 READER & SENS |
| Device Expiration Date | 2019-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-23 |