MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-04 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[71906515]
A biom? Rieux investigation was conducted. The submitted isolate was subcultured and the vitek? 2 gn card testing included individual organism suspensions on each of the two customer implicated lots (b)(4), as well as a random lot, in duplicate. The api 20 e test strip was also perfomed. All six (6) gn cards tested resulted in the same low discrimination identification of proteus penneri/proteus hauseri. The api 20 test strip resulted in an excellent identification (b)(4) of proteus vulgaris group. Note, the isolate demonstrated was swarming on tsab agar, compatible with an identification of proteus vulgaris. A review of the customer's proteus penneri/proteus hauseri data against expected reactions for proteus vulgaris demonstrated five (5) atypical negative reactions (off, bglu, proa, 0129r and ggaa) contributing to the misidentification according to the gn knowledge base. Review of the internal proteus penneri/proteus hauseri data demonstrated three of the same atypical negative reactions (bglu, proa and ggaa). An increased number of atypical negative results can indicate a strain with decreased viability or an atypical strain. The investigation concluded the isolate exhibits atypical growth behavior. The vitek? 2 gn card is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[71906516]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of a proteus vulgaris external control strain as proteus penneri in association with the vitek? 2 gn test kit. The repeat test obtained proteus hauseri. There was no patient involvement associated with the quality control strain. The customer submitted the isolate to biom? Rieux for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00109 |
| MDR Report Key | 6457616 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-04 |
| Date of Report | 2017-04-04 |
| Date Mfgr Received | 2017-03-08 |
| Device Manufacturer Date | 2016-10-23 |
| Date Added to Maude | 2017-04-04 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK? 2 GN TEST KIT |
| Generic Name | VITEK? 2 GN TEST CARD |
| Product Code | JTO |
| Date Received | 2017-04-04 |
| Catalog Number | 21341 |
| Lot Number | 241396640 |
| Device Expiration Date | 2017-10-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC |
| Manufacturer Address | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-04 |