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 2019-09-04 for BACT/ALERT? MP PLUS 259797 manufactured by Biomerieux Inc..
[188245811]
A customer from great britain notified biom? Rieux of obtaining false negative results when testing a neqas mycobacterium tuberculosis (m. Tuberculosis) sample with the bact/alert? Mp (plastic) bottle (reference 259797); no lot number has been provided. The customer confirmed the bottles were assigned negative after forty two (42) days of incubation. As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health. Biom? Rieux will initiate an internal investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2019-00057 |
| MDR Report Key | 8960522 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-09-04 |
| Date of Report | 2019-09-04 |
| Date Mfgr Received | 2019-08-05 |
| Date Added to Maude | 2019-09-04 |
| 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? MP PLUS |
| Generic Name | BACT/ALERT? MP PLUS |
| Product Code | MDB |
| Date Received | 2019-09-04 |
| Catalog Number | 259797 |
| 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 | 2019-09-04 |