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 2017-05-16 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[75331835]
A customer from the united states reported to biom? Rieux a misidentification of a clostridium septicum cap survey sample as clostridium perfrigens in association with the vitek? 2 anc test kit (udi (b)(4)). The first survey swab was subbed to initial plates, incubated for 24 hours then subbed to brucella agar and incubated for 48 hours. The isolate was re-subbed to brucella agar, incubated 48 hours and tested. A result of clostridium perfrigens (85%) was reported. After the customer received the cap results, the second swab received was subbed to initial plates, incubated for 24 hours then tested, in which the expected id of clostridium septicum (97%) was obtained. There was no patient involvement as this was a survey sample. The customer submitted lab reports from the testing of both swabs and the cap summary report for evaluation. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00157 |
| MDR Report Key | 6570512 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-16 |
| Date of Report | 2017-07-11 |
| Date Mfgr Received | 2017-06-13 |
| Device Manufacturer Date | 2016-09-04 |
| 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 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 | 2017-05-16 |
| Catalog Number | 21347 |
| Lot Number | 2440100103 |
| ID Number | 03573026144364 |
| 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 | 2017-05-16 |