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..
[186598746]
A customer in (b)(6) 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: female cancer patient receiving chemotherapy. A result of an oxidase positive gram-negative bacillus was provided to the treating physician. The patient was given preventative treatment and an antibiogram was done. 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 adverse patient impact; the patient received preventative treatment based upon an erroneous test result. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2020-00003 |
| MDR Report Key | 9861374 |
| 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 |
| Catalog 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 |