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 2019-03-22 for BACT/ALERT ? BPN 279019 manufactured by Biomerieux Inc..
[139824429]
A customer in the united states notified biom? Rieux of two false positive results while using bact/alert? Bpn bottles (reference# 279019 lot# 1051492). These bottles flagged positive and were sub-cultured. They did not exhibit growth, which indicated false positive results. The customer confirmed that they are following the instructions for use and did not note any anomalies with sample preparation or the bottles. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to any patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2019-00007 |
| MDR Report Key | 8444841 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-22 |
| Date of Report | 2019-08-29 |
| Date Mfgr Received | 2019-08-01 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-03-22 |
| 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. CANDACE MARTIN |
| 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 ? BPN |
| Generic Name | BACT/ALERT ? BPN |
| Product Code | MZC |
| Date Received | 2019-03-22 |
| Catalog Number | 279019 |
| Lot Number | 1051492 |
| 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 | 2019-03-22 |