MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-02-23 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[68367209]
A customer from the (b)(6) reported to biom? Rieux a misidentification of citrobacter amalonaticus as serratia odorifera, for a blood culture from a dialysis patient, in association with vitek 2 gn test kit. The technicians determined the isolate was not serratia odorifera based on culture smell, which prompted testing of the isolate with an alternative method (microscan). The result was citrobacter amalonaticus. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. The customer sent the test reports to biom? Rieux and sent the isolate to an external lab for testing. A field service engineer was scheduled to visit the customer site. A biomerieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[75223410]
A customer from the united states reported to biom? Rieux a misidentification of citrobacter amalonaticus as serratia odorifera in association with vitek? 2 gn test kit. An internal biom? Rieux investigation was performed. The organism was subbed and testing included both the customer lot and a random lot of vitek? 2 gn cards. Api? 20 e was performed, as was vitek? Ms and 16s sequencing. On both cards tested, an excellent id (99%) of s. Odorifera was obtained. Api? 20 e gave a good identification to the genus of pantoea. Vitek? Ms gave an identification of leclercia adecarboxylata (99. 9% confidence value). However, when 16s sequencing was performed, a 99% identity match to both enterobacter amnigenus and leclercia sp. Was obtained. A comparison of card reaction results for s. Odorifera against the expected reaction results for e. Amnigenus resulted in one (1) atypical positive reaction (ellm). A comparison of card reaction results for s. Odorifera against the expected reaction results for l. Adecarboxylata resulted in two (2) atypical positive reactions (dsor, cit). Conclusion: atypical strain.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00067 |
| MDR Report Key | 6354825 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-23 |
| Date of Report | 2017-05-01 |
| Date Mfgr Received | 2017-04-06 |
| Device Manufacturer Date | 2017-08-27 |
| Date Added to Maude | 2017-02-23 |
| 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 KIT |
| Product Code | JTO |
| Date Received | 2017-02-23 |
| Catalog Number | 21341 |
| Lot Number | 241390940 |
| Device Expiration Date | 2017-08-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-02-23 |