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 2016-12-20 for VITEK?2 ANC TEST KIT 21347 manufactured by Biomerieux Inc..
[62857896]
A customer from the united states reported to biom? Rieux a misidentification of api survey sample bacteroides unformis as bacteroides thetaiotaomicron, in association with the vitek? 2 anc test kit. The customer repeated the test three times. Twice the results were 95% very good identification for b. Thetaiotaomicron and once a 99% excellent identification for b. Thetaiotaomicron. The customer confirmed that the isolates were cultured on the cdc medium. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[68618895]
A customer from the united states reported to biom? Rieux a misidentification of api survey sample bacteroides unformis as bacteroides thetaiotaomicron, in association with the vitek? 2 anc test kit. An internal biom? Rieux investigation was performed. The organism was sub cultured on cba media and grown anaerobically for 48 hrs. Testing included two (2) customer lots and a random lot of anc cards. Vitek? Ms and 16s sequencing was also performed. On all cards tested, a very good (95%) or excellent id (98%) of b. Thetaiotamicron was obtained. For testing on the vitek? Ms, a 99. 9% identity match of b. Thetaiotamicron was obtained. 16s sequencing gave a 100% identity match to b. Thetaiotamicron. When the organism's 16s sequence was compared against the 16s sequence for b. Uniformis, there was only a 92% identity match. Therefore, the final identification is b. Thetaiotamicron. Vitek? 2 anc cards were determined to be performing as expected and no further action is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00207 |
| MDR Report Key | 6188570 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-12-20 |
| Date of Report | 2017-02-27 |
| Date Mfgr Received | 2017-01-31 |
| Date Added to Maude | 2016-12-20 |
| 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 | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 ANC TEST KIT |
| Generic Name | VITEK?2 ANC TEST CARD |
| Product Code | JSP |
| Date Received | 2016-12-20 |
| Catalog Number | 21347 |
| Lot Number | 2440062203 |
| Device Expiration Date | 2018-01-27 |
| 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 HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-20 |