MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-08-01 for BACT ALERT 3D INSTRUMENT 43002-901 manufactured by Biomerieux, Inc..
[485108]
The bact 3d instrument is used with blood culture bottles to detect microbial growth. The complaint was regarding a customer suspecting possible galse negatives when using bact/alert pf bottles. Further analysis of 37 bottles indicated 3 possible positive results at the end of the recommended incubation period for the samples. The results were however, considered to be inconclusive. The two patients involved had a history of reporting consistently negative blood cultures. Treatment on the two pts was based on the initial negative results and neither pt received antifungal treatment. No adverse events have been reported since this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00027 |
| MDR Report Key | 719653 |
| Report Source | 07 |
| Date Received | 2005-08-01 |
| Date of Report | 2005-07-25 |
| Date of Event | 2005-06-22 |
| Date Mfgr Received | 2005-06-22 |
| Date Added to Maude | 2006-05-30 |
| 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 | NANCY OLSCAMP, SR. SPECIALIST |
| Manufacturer Street | 100 RODOLPHE ST. |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202879 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT ALERT 3D INSTRUMENT |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2005-08-01 |
| Model Number | NA |
| Catalog Number | 43002-901 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 708722 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US |
| Baseline Brand Name | BACT ALERT 3D INSTRUMENT |
| Baseline Generic Name | MICROBIAL GROWTH MONITOR |
| Baseline Model No | NA |
| Baseline Catalog No | 43002-901 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-01 |