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 2018-04-27 for VITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT 21343 manufactured by Biomerieux, Inc.
[107349914]
An industry customer from (b)(6) notified biom? Rieux of misidentification results when testing candida albicans quality control strain, atcc (b)(4), with vitek? 2 yst test kit (ref. 21343), lot. # 2430555203. The customer stated that vitek 2 obtained an identification as stephanoascus ciferrii species. The customer stated that he used the strain after three to five days of incubation at 22. 5? C. The strain was grown on sda media before testing on vitek 2, and the customer used a mcfarland at 1. 8-2. 2. Based on data provided by the customer, the instructions for use were not followed during this first testing as the strain needs to be no older than three days and incubation needs to be done at 30? To 37? C, aerobic non -co2 conditions. Therefore, the customer was requested to perform a retest following the instructions for use. Upon retesting, the customer obtained the same misidentification result of st. Ciferrii species. There is no indication or report from the laboratory that the discrepant quality result led to any adverse event related to any patient's state of health. There was no patient associated with this quality control sample. To be noted, as specified in the instructions for use (ref. (b)(4)) this atcc strain is not recommended to perform qc testing with vitek? 2 yst cards. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00166 |
| MDR Report Key | 7470256 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-27 |
| Date of Report | 2018-07-10 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2017-12-03 |
| Date Added to Maude | 2018-04-27 |
| 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. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 YEAST (YST) IDENTIFICATION (ID) TEST KIT |
| Generic Name | VITEK? 2 YST ID TEST KIT |
| Product Code | JXB |
| Date Received | 2018-04-27 |
| Catalog Number | 21343 |
| Lot Number | 2430555203 |
| Device Expiration Date | 2019-06-04 |
| 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 | 2018-04-27 |