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 2017-05-16 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux, Inc.
[75417151]
A customer from france reported to biom? Rieux a misidentification of a campylobacter jejuni jejuni strain (atcc 33560 lot 111-38-1) as campylobacter coli in association with the vitek? 2 nh test kit (udi (b)(4)). The customer tested the strain at 24 and 48 hours immediately after incubation. The customer obtained a result of low discrimination and selected campylobacter jejuni jejuni without complementary testing. The second test result was campylobacter coli. The conforming quality control id was eikenella corrodens. There was no patient involvement as the customer was performing a control test for campylobacter strains. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00155 |
| MDR Report Key | 6570328 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-16 |
| Date of Report | 2017-08-31 |
| Date Mfgr Received | 2017-08-09 |
| Device Manufacturer Date | 2016-11-05 |
| Date Added to Maude | 2017-05-16 |
| 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 |
| Manufacturer Country | FR |
| 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 NH TEST KIT |
| Generic Name | VITEK? 2 NH TEST CARD |
| Product Code | JTO |
| Date Received | 2017-05-16 |
| Catalog Number | 21346 |
| Lot Number | 2450162203 |
| ID Number | 03573026144357 |
| Device Expiration Date | 2018-05-08 |
| 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 | 2017-05-16 |