MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for JQPARROW - MYLA V4.1 DL360 CLI 420347 manufactured by Biomerieux, Inc..
[146224461]
A customer in (b)(6) notified biom? Rieux of bact/alert? Fn plus bottle that was not incubated for the correct amount of time on the virtuo? Due to an inadvertent operator error using the myla? Version 4. 1 software (item# 420347, serial# (b)(4)). The bottle was incubated for seven (7) days rather than the expected ten (10) days. The customer indicated that the shortened incubation time of the fn plus bottle caused the treating physician to postpone a vascular tissue graft procedure for the patient. At the time of this report, the customer has provided no further details related to the patient condition or if the vascular tissue graft has been completed. A biom? Rieux internal investigation will initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615754-2019-00040 |
| MDR Report Key | 8641696 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-11-21 |
| Date Mfgr Received | 2019-10-24 |
| Date Added to Maude | 2019-05-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER ARMSTRONG |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145068201 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JQPARROW - MYLA V4.1 DL360 CLI |
| Generic Name | ARROW - MYLA V4.1 DL360 CLI |
| Product Code | OUG |
| Date Received | 2019-05-24 |
| Model Number | 420347 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-24 |