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 CLASSIC WITH BACT/VIEW 201087 NA manufactured by Biomerieux, Inc..
[541268]
Customer reported bact/alert classic system (bact/view c. 30 software) detected positive platelet unit, but delayed sending result to lis. On 09/02/06, bact/view reported "clocks unsynchronized" error in main monitor window and prompted user to enter correct date/time. No user present to respond. Bact/view, as expected, performed no automated functions, including 10-minute "ping" of site lis. Site lis sent alarm indicating bact/view had stopped communicating. Site then checked system. On 09/03/06, user resynchronized clocks by acknowledging error window and system appeared to return to normal operation. Backlogged/new readings started processing and lis "pings" resumed. Then, positive bpa bottle detected and reported in monitor window. No user present to see message. Bact/view continued processing data normally but did not run scheduled macro to send new test results to site lis due to defect in bact/view software code that displays "clocks unsynchronized" window. On 09/04/06, user noticed positive bottle message in monitor window. Upon touching bact/view screen, monitor window re-activated and bact/view resumed running scheduled macros. Macro then sent positive result to lis. Site recalled platelet unit, which was released for use prior to flagging positive. Unit had not been transfused, and so there was no injury.
Patient Sequence No: 1, Text Type: D, B5
[8055935]
In classic instrument configurations, bact/view itself is responsible for analyzing bottle readings to detect positives and negatives. The "clocks unsynchronized" error is a normal error condition in which bact/view detects that the instrument's clock has drifted more than 5 minutes from the computer's clock. These clocks must be in sync for bact/view to trust the timing of readings from the classic instrument. During this time, the instrument continues to collect readings, although bact/view deliberately delays processing them until the clocks are resynchronized and the times can be trusted. The defect is that bact/view still thinks the "clocks unsynchronized" window is the "current" window even after it is dismissed by the user. Scheduled macros are only run when the "monitor" window is thought to be the current window, and so when this defect occurs, bact/view does not run them. Once a user touches the screen, the "monitor" window is activated, causing bact/view to know it is the current window, and scheduled macros are resumed. This defect is the result of the complex design of the method by which it must track the "current" window. This complex design was necessary to work around other known defects in openinsight, a third-party commercial software product on which bact/view is built. This defect has been present in all versions of bact/view since the product was first launched in 1996, although its existence was unknown until this investigation. The defect is not fixed or otherwise affected by the bact/view c. 30a patch version launched earlier this year. The defect occurs only in classic instrument configurations of bact/view.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2006-00003 |
| MDR Report Key | 797483 |
| Report Source | 07 |
| Date Received | 2006-12-13 |
| Date of Report | 2006-12-07 |
| Date of Event | 2006-09-02 |
| Date Mfgr Received | 2006-10-02 |
| Date Added to Maude | 2006-12-26 |
| 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 | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT CLASSIC WITH BACT/VIEW |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2006-12-13 |
| Model Number | 201087 |
| Catalog Number | NA |
| 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 | 785016 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Baseline Brand Name | BACT/ALERT CLASSIC WITH BACT/VIEW |
| Baseline Generic Name | MICROBIAL GROWTH MONITOR |
| Baseline Model No | 201087 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-13 |