MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-06 for BACT/ALERT? IAST 259786 manufactured by Biomerieux Inc..
[95736872]
A customer in the united states notified biom? Rieux of a false negative result associated with bact/alert? Iast (reference 259786). The iast lots are industry specific lots and are often used at the usp temperature 22. 5 c and expected to recovery aerobic staph aureus in < 5 days. There is no reported adverse event associated with the laboratory user of this product. This product is not for clinical use; however, there is a similar product that is used in a clinical application. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00397 |
| MDR Report Key | 7086436 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-06 |
| Date of Report | 2018-02-21 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2017-04-16 |
| Date Added to Maude | 2017-12-06 |
| 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. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? IAST |
| Generic Name | BACT/ALERT? IAST |
| Product Code | MZC |
| Date Received | 2017-12-06 |
| Catalog Number | 259786 |
| Lot Number | 1048728 |
| Device Expiration Date | 2018-04-11 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-06 |