MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-29 for FREESTYLE LIBRE manufactured by Abbott.
[104139584]
Abbotts freestyle libre prescription assistance through online signup was supposed to assist with the procurement of the libre continuous monitor. The service was unable to complete the ordering because of gross administrative issues thereby delaying the prescription by weeks and imposing undue stress to me. This service is a marketing tool that does not help the patient but harms. In addition the pharmaceutical company abbott does not require the pharmacies, like (b)(6), to supply the control solutions to properly use the product safety, as required by the manufacturers instructions, and fda compliance requirements. I believe pharmacies should fully supply all of the devices and control solutions to safety use a prescription device according to manufacturers instructions. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076234 |
| MDR Report Key | 7384683 |
| Date Received | 2018-03-29 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-03-27 |
| Date Added to Maude | 2018-03-30 |
| 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 |
| 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 ANALYSIS SOFTWARE |
| Product Code | PHV |
| Date Received | 2018-03-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-29 |