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 2017-09-06 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[85000494]
A customer from (b)(6) reported to biom? Rieux a misidentification for a clostridium septicum (atcc 12464) quality control strain in association with the vitek? 2 anc test kit (lot 2440100103). On (b)(6) 2017, initial testing with the anc card gave a result of low discrimination c. Septicum. On (b)(6) 2017 repeat test results were lactobacillus gasseri and unidentified organism. The customer reported using cos media for the subculture and testing at 24 hours. There was no patient involvement as this event involved a quality control sample. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00293 |
| MDR Report Key | 6845162 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-06 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-05-20 |
| Date Mfgr Received | 2017-10-12 |
| Device Manufacturer Date | 2016-09-04 |
| Date Added to Maude | 2017-09-06 |
| 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 | 2017-09-06 |
| 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 | 2017-09-06 |