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 2016-12-30 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[63693489]
A customer from the united states reported to biom? Rieux a misidentification of an (b)(4) survey sample in association with the vitek? 2 anc test kit. Initial and repeat testing of the wound sample with vitek? 2 anc identified bacteroides thetaiotaomicron (98%). The customer stated that the correct (b)(4) organism was bacteroides uniformis. The test reports and isolate have been requested from the customer. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[68619078]
A customer from the united states reported to biom? Rieux a misidentification of an american proficiency institute (api) survey sample in association with the vitek? 2 anc test kit. An internal biom? Rieux investigation was performed. The organism was subbed 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 | 1950204-2016-00218 |
| MDR Report Key | 6215821 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-12-30 |
| Date of Report | 2017-02-27 |
| Date Mfgr Received | 2017-01-31 |
| Date Added to Maude | 2016-12-30 |
| 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 | 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 ANC TEST KIT |
| Generic Name | VITEK? 2 ANC TEST CARD |
| Product Code | JSP |
| Date Received | 2016-12-30 |
| Catalog Number | 21347 |
| Lot Number | 244370520 |
| Device Expiration Date | 2017-02-04 |
| 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 | 2016-12-30 |