MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-08-31 for BACT/ALERT 3D INSTRUMENT 210147 manufactured by Biomerieux, Inc..
[709821]
The bact/alert 3d instrument is used with blood culture bottles to detect microbial growth. There was a delay in reporting results due to a communication issue between the controller module and the incubator module. Since the incubator module was unavailable, there were no data to report. Subcultures were performed on all 100 bottles. Only one bottle with staph. Coagulase was identified and the user thinks this was a contaminate due to failure to properly decontaminate the top of the bottle.
Patient Sequence No: 1, Text Type: D, B5
[7813916]
An investigation into this complaint has been initiated. The field service engineer indicated that the event was caused by a lis session record which contained an errant character (&). The customer is using the b. 12 version of the software, and this version interprets the "&" as an escape delimiter causing the bta 3d to automatically reboot. According to instrument status, the "incubation module temporarily unavailable while power up initiation takes place". This event occurred on the weekend and user was not on site to respond and to correct or eliminate the lis session record at fault. The lis repeatedly sent the errant character, the bta 3d repeatedly rebooted; and thus, the incubator module was not operational. The corrective action for this issue is installation of the mandatory bact/alert 3d software update--version b. 25 which was approved for implementation on 30 october 2006.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2007-00005 |
| MDR Report Key | 906888 |
| Report Source | 07 |
| Date Received | 2007-08-31 |
| Date of Report | 2007-08-31 |
| Date of Event | 2007-08-04 |
| Date Mfgr Received | 2007-08-04 |
| Date Added to Maude | 2007-10-11 |
| 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 | JAMES CLINTON |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT 3D INSTRUMENT |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2007-08-31 |
| Catalog Number | 210147 |
| Lot Number | 601CM5111 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 890198 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-31 |