MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-20 for BACT/ALERT? FA PLUS 410851 manufactured by Biomerieux Inc..
[185114036]
A customer in france notified biom? Rieux of post bottle inoculation contamination for a patient in association with the bact/alert? Fa plus blood culture bottles (ref. 410851, lot 4054200). Patient : male in intensive care. The doctor determined that this patient's result was a contaminant. Pcr was performed on the impacted patient bottles; all bottles obtained an identification of advenella kasmirensis. Biom? Rieux customer service confirmed advenella kasmirensis is an environmental organism. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2020-00004 |
| MDR Report Key | 9861421 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-03-20 |
| 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 | 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 | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? FA PLUS |
| Generic Name | BACT/ALERT? FA PLUS |
| Product Code | MDB |
| Date Received | 2020-03-20 |
| Model Number | 410851 |
| Lot Number | 4054200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |