MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2017-11-07 for BACT/ALERT? IAST 259786 manufactured by Biomerieux Inc..
[92504538]
A customer in germany notified biom? Rieux of a false negative result associated with bact/alert? Iast (reference 259786). The customer reported that the bottles did not pass the growth promotion test. Staphylococcus aureus (bioball ref. 56045) did not grow within seven ( 7) days (according to the ep). The customer tested two bottles: bioball batch 3787 - days until no detection: no growth (9. 1 days), bioball batch 3787 - days until detection: no growth (10 days). The customer could not use the lot. 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 | 3002769706-2017-00330 |
| MDR Report Key | 7007002 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2017-11-07 |
| Date of Report | 2017-12-01 |
| Date Mfgr Received | 2017-11-09 |
| Device Manufacturer Date | 2016-10-28 |
| Date Added to Maude | 2017-11-07 |
| 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 | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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? IAST |
| Generic Name | BACT/ALERT? IAST |
| Product Code | MZC |
| Date Received | 2017-11-07 |
| Catalog Number | 259786 |
| Lot Number | 1047747 |
| Device Expiration Date | 2017-10-23 |
| Device Availability | * |
| 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 | 2017-11-07 |