MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-01 for BACT/ALERT? BPN CULTURE BOTTLE 279019 manufactured by Biomerieux Inc..
[109760716]
A customer in the united states notified biom? Rieux of a false negative result associated with bact/alert? Bpn bottle (reference 279019). The customer reported during testing, 19 out of 20 bottles were positive, and one (1) bottle was negative. All 20 bottles were sub-cultured on plates and grew p. Acnes, including the bottle that flagged negative after five (5) days. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00073 |
| MDR Report Key | 7559937 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-01 |
| Date of Report | 2018-08-08 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-06-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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? BPN CULTURE BOTTLE |
| Generic Name | BACT/ALERT? BPN CULTURE BOTTLE |
| Product Code | MZC |
| Date Received | 2018-06-01 |
| Catalog Number | 279019 |
| Lot Number | 1049001 |
| Device Expiration Date | 2018-06-07 |
| 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 | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-01 |