MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for QS1 - NRX manufactured by J M Smith Corporation.
[133195913]
Prescription was input into our software(qs1-nrx) as humulin r and the system linked and substituted to novolin r. We contacted qs1 and they replied with, "we can have you request an enhancement". Therefore they do not consider such an error to be worthy of fixing. Upon further review, our system tries to link other non ab rated insulins together, so we are watching carefully for more software errors until we switch from qs1 next month. Qs1 has also had this response to other errors with their system in the past. Please let me know if you'd like further details , thanks. (b)(6). Access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083017 |
| MDR Report Key | 8233591 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date Added to Maude | 2019-01-10 |
| 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 | UNKNOWN |
| 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 | QS1 - NRX |
| Generic Name | MEDICAL DEVICE DATA SYSTEM |
| Product Code | OUG |
| Date Received | 2019-01-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J M SMITH CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-08 |