MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-12-16 for BACT/ALERT 3D MICROBIAL DETECTION SYSTEM 210147 NA manufactured by Biomerieux, Inc..
[408397]
The customer called co in 2005 for assistance in clearing a string space format error on their bact/view software. When a string space format error occurs, the bact/view computer will stop communicating with a lis system until the error is cleared. The customer informed co during this call of a positive bact/alert bottle result that was not transmitted to their lis during the time before the error message was cleared. The lab was not staffed on sunday, and they had turned off their system's audible alarms. They did not realize that a bottle had gone positive, and that the bact/view computer was no longer communicating with their lis system until late morning of the same day. The customer called co back the next day in the evening to inform co that the pt who received the contaminated platelets had died. The blood bank determined that the platelets were contaminated with e-coli.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2005-00035 |
| MDR Report Key | 655758 |
| Report Source | 07 |
| Date Received | 2005-12-16 |
| Date of Report | 2005-12-13 |
| Date of Event | 2005-11-20 |
| Date Mfgr Received | 2005-11-21 |
| Date Added to Maude | 2005-12-27 |
| 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 | 0 |
| Manufacturer Contact | BRIAN BRUNDIDGE |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2005-12-16 |
| Model Number | 210147 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 645246 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Baseline Brand Name | BACT/ALERT 3D MICROBIAL DETECTION SYSTEM |
| Baseline Generic Name | MICROBIAL GROWTH MONITOR |
| Baseline Model No | 210147 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-12-16 |