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 2020-02-07 for BACT/ALERT? FA PLUS 410851 manufactured by Biomerieux Inc..
[185498604]
A customer from the netherlands notified biom? Rieux of obtaining a false negative culture bottle result in association with the bact/alert? Fa plus culture bottle (ref. 410851, lot 4053406). The customer stated the patient had two sets of bottles processed, each set included one fa plus (aerobic) bottle and one fn plus (anaerobic bottle). Patient bottle results are listed below. Set 1: fa plus positive and fn plus positive. Set 2: fa plus negative and fn plus positive. The negative fa plus bottle was removed after five days of incubation, and identified to have a yellow sensor and dirty broth. The bottle gram stain showed presence of gram positive cocci. The sub-culture identified the gram positive cocci as enterococcus faecalis. The customer stated that bottle entry into the instrument had a delay of sixteen hours. It is unknown if the bottle sensor was already yellow at the time of entry. There is no adverse patient impact, positive results were obtained with the first set of blood culture bottles therefore the false negative result had no adverse impact to the patient? S state of health. Biom? Rieux will initiate an internal investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2020-00002 |
| MDR Report Key | 9683853 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-04-01 |
| Date Added to Maude | 2020-02-07 |
| 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 | 2020-02-07 |
| Catalog Number | 410851 |
| Lot Number | 4053406 |
| Device Expiration Date | 2020-03-26 |
| 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 | 2020-02-07 |