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 2017-01-31 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[66219682]
A customer from the united states reported to biomerieux a misidentified api survey sample of bacteroides uniformis (95%) as bacteroides thetaiotaomicron (98%), in association with the vitek? 2 anc test kit. The customer stated there were no instrument errors. There was no patient involvement as the isolate was a survey sample. The test reports were requested from the customer. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[68401089]
A customer from the united states reported to biomerieux a misidentified api survey sample of bacteroides uniformis (95%) as bacteroides thetaiotaomicron (98%), in association with the vitek? 2 anc test kit. An internal biom? Rieux investigation was performed. The api survey organism (api wo-02) was subbed on cba media and grown anaerobically for 48 hrs. Testing included two (2) customer lots and a random lot of anc cards. Testing with vitek? Ms and 16s sequencing was also performed. All cards tested gave a very good (95%) or excellent id (98%) of b. Thetaiotamicron with the vitek? 2. Testing with the vitek? Ms obtained a 99. 9% identity match of b. Thetaiotamicron. The 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. The investigation concluded that the vitek? 2 anc test cards are performing as expected and no further action is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00038 |
| MDR Report Key | 6291407 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-31 |
| Date of Report | 2017-02-27 |
| Date Mfgr Received | 2017-01-31 |
| Device Manufacturer Date | 2016-09-04 |
| Date Added to Maude | 2017-01-31 |
| 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 ANC TEST KIT |
| Generic Name | VITEK? 2 ANC TEST CARD |
| Product Code | JSP |
| Date Received | 2017-01-31 |
| Catalog Number | 21347 |
| Lot Number | 2440100103 |
| Device Expiration Date | 2018-03-06 |
| 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 | 2017-01-31 |