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 2019-08-17 for BACT/ALERT? FN PLUS 410852 manufactured by Biomerieux Inc..
[188990342]
A customer in (b)(6) notified biom? Rieux of obtaining two false negative results in association with the bact/alert? Fn plus blood culture bottles (reference 410852, lot 4052871). The customer stated both bottles were incubated for five days and flagged negative. These bottles were then sub-cultured and were positive for growth of propionibacterium acnes (p. Acnes). Although the customer did follow the five day incubation protocol, p. Acnes is a fastidious slow growing microorganism which may require a longer incubation period. The bottle instructions for use (ifu) notes this a limitation of the test if fastidious microorganisms are suspected. 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 | 3002769706-2019-00049 |
| MDR Report Key | 8904289 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-08-17 |
| Date of Report | 2019-08-17 |
| Date Mfgr Received | 2019-07-21 |
| Device Manufacturer Date | 2019-01-21 |
| Date Added to Maude | 2019-08-17 |
| 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 | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? FN PLUS |
| Generic Name | BACT/ALERT? FN PLUS |
| Product Code | MDB |
| Date Received | 2019-08-17 |
| Catalog Number | 410852 |
| Lot Number | 4052871 |
| 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 | 2019-08-17 |