MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-12-13 for BACT/ALERT 3D INSTRUMENT 200388 50025225 manufactured by Biomerieux, Inc..
[20509957]
The bact/alert 3d instrument is used with blood culture bottles to detect microbial growth. This complaint was from the blood center, where a single bact/alert 3d cell was identified as having stopped taking readings at 2. 8 days of incubation without alerting the customer. This 3d instrument was running version b. 12 control module firmware. During unload following maximum test time, the bottle in questions was noticed to have a yellow sensor. Confirmatory testing was performed by customer and determined gram positive cocci growth. Partial platelet unit was already transfused in patient, however, no adverse events were reported for this patient. The other partial unit expired prior to transfusion.
Patient Sequence No: 1, Text Type: D, B5
[20830651]
The investigation into the complaint has been completed. Following review of the instrument back-ups, a definitive conclusion could not be made as to what sequence of events caused this issue to occur. The recently released b. 25 version of the control module firmware for the bact/alert 3d instrument has logging capability that can capture instrument events occuring over the last 30 days of use. If new information regarding this complaint becomes available, this report will be updated. This report has been submitted late because the associated complaint was originally determined to be not reportable. However, during further evaluation by management, a decision was made to file this complaint as a reportable event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2006-00001 |
| MDR Report Key | 796771 |
| Report Source | 07 |
| Date Received | 2006-12-13 |
| Date of Report | 2006-12-07 |
| Date of Event | 2006-06-23 |
| Date Mfgr Received | 2006-06-23 |
| Date Added to Maude | 2006-12-22 |
| 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 | BRIAN 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 3D INSTRUMENT |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2006-12-13 |
| Model Number | 200388 |
| Catalog Number | 50025225 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 784323 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Baseline Brand Name | BACT/ALERT 3D INSTRUMENT |
| Baseline Generic Name | MICROBIAL GROWTH MONITOR |
| Baseline Model No | 200388 |
| Baseline Catalog No | 50025225 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-13 |