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 50025837 manufactured by Biomerieux, Inc..
[541144]
The bact/alert 3d instrument is used with blood culture bottles to detect microbial growth. This customer was using the system to test platelet units. The complaint involved the loss of the bact/alert bpa algorithm on a bact 3d instrument following replacement of the flash memory card. Following the memory replacement, an error code was rec'd when loading bottles. During troubleshooting efforts, it was recognized that the bpa algorithm was not present, thus resulting in the noted error code. Following re-installation of this algorithm, the error codes no longer appeared when loading bottles. Even though the instrument alerted the user with an error code and alarm, twenty five (25) samples loaded following this memory replacement were analyzed under the wrong algorithm as the default was not the same as the missing bpa algorithm. All samples in question were recalled by the customer except for one that had been transfused. There was no adverse pt impact reported for the sample that had been transfused.
Patient Sequence No: 1, Text Type: D, B5
[8055456]
The customer was using a 3d instrument which had bpa/bpn bottles activated. The 3d instrument went down for reasons unknown and a service engineer (se) replaced the 3d's flash memory card. The se either did not make a backup of the old flash card, or was not able to restore the backup onto the new flash card. The flash card contains all configuration information and knowledge about all bottles loaded. Since the flash card was not restored with a previous backup, the 3d restarted without memory of the bottles already loaded. Also, bpa/bpn bottles were no longer activated. The 3d discovered bottles loaded in its cells and regarded them all as anonymous. Since these bottles had all lost their histories, results from these bottles could not be trusted, regardless of the algorithm that the 3d assigned them going forward. They should all have required subculture or new samples retested. The user attempted to load new bpa/bpn bottles into the 3d. Since the bpa/bpn bottles were no longer activated, when the user attempted to load a bpa/bpn bottle by scanning its id, the 3d displayed "generic" as the bottle type and alarmed by beeping repeatedly until either the bottle was loaded or the user selected some non-generic bottle type from the screen. Although this is expected behavior by a 3d following this type of event, the customer contacted service because this behavior was unexpected by the user. The next day the customer was notified that the bottles loaded following the flash memory replacement were not being tested properly and the customer determined that the released units should be recalled. The se returned and properly activated the bpa/bpn bottle algorithms. If new information regarding this complaint becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2006-00002 |
| MDR Report Key | 797469 |
| Report Source | 07 |
| Date Received | 2006-12-13 |
| Date of Report | 2006-12-07 |
| Date of Event | 2006-09-16 |
| Date Mfgr Received | 2006-09-16 |
| 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 | 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 | 50025837 |
| 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 | 785002 |
| 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 |