MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-08-22 for BACT/ALERT FA CULTURE BOTTLES 259791 NA manufactured by Biomerieux, Inc..
[19684372]
This complaint involved a single pt on which 3 blood cultures were performed. After 24 hours, plate cultures were positive for pseudomonas aeruginosa. The inoculated bact/alert fa bottles remained negative after 10 days incubation. There was no adverse effect on the pt as a result of these false negative results. There were no injuries or deaths associated with this incident. No improper treatment was given nor was any required, treatment delayed because of the analysis results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00030 |
| MDR Report Key | 703655 |
| Report Source | 07 |
| Date Received | 2005-08-22 |
| Date of Report | 2005-08-19 |
| Date of Event | 2005-07-14 |
| Date Added to Maude | 2006-04-27 |
| 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 | BRAIN BRUNDIDGE, STAFF SPEC. |
| Manufacturer Street | 100 RODOLPHE ST. |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202968 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT FA CULTURE BOTTLES |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2005-08-22 |
| Model Number | 259791 |
| Catalog Number | NA |
| Lot Number | 1003139 |
| ID Number | NA |
| Device Expiration Date | 2005-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 692763 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Baseline Brand Name | BACT/ALERT FA PLASTIC BOTTLE |
| Baseline Generic Name | MICROBIAL GROWTH MONITOR |
| Baseline Model No | NA |
| Baseline Catalog No | 259791 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-22 |