MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-12 for BACT/ALERT 3D MICROBIAL DETECTION SYSTEM 210147 manufactured by Biomerieux, Inc..
[748961]
Two racks in the bact/alert 3d instrument did not take reflectance readings to monitor microbial growth for a day. Instrument failed to notify user that machine was not taking readings. The bottles were moved to other racks and monitoring began. Technician subcultured affected bottles as recommended when gaps in monitoring occur. There were no deaths or adverse events related to this incident. However, if this type of alleged malfunction were to recur causing data loss or delayed results undetected by the user in a blood bank, then there is potential for an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[8040745]
An investigation of this event has been initiated. Findings from this investigation are not yet available. Addition information will be submitted when investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2007-00007 |
| MDR Report Key | 972723 |
| Report Source | 06 |
| Date Received | 2007-12-12 |
| Date of Report | 2007-12-12 |
| Date of Event | 2007-11-12 |
| Date Mfgr Received | 2007-11-12 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2008-04-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH FRITZ |
| Manufacturer Street | 100 RODOLPHE ST |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202682 |
| Single Use | 3 |
| Previous Use Code | 3 |
| 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 | 2007-12-12 |
| Model Number | 210147 |
| Lot Number | 101CM1504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 977867 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-12 |