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 2017-02-16 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[67661187]
A customer from (b)(6) reported to biom? Rieux a susceptibility issue for fluconazole with four (4) candida albican urine samples in association with the vitek? 2 ast-ys07 test kit. The customer tested four (4) patient isolates on three (3) vitek? Instruments with test results ranging from susceptible to resistant (mic < 0. 12 to 32). The customer also tested the isolates with an alternative method and the results were susceptible. The customer reported a delay in reporting results due to retests. They were uncertain if a wrong result was reported to a physician as they did not know which result was correct in some cases. The customer reported that a patient was not harmed or treated incorrectly. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. The isolates and test reports were requested from the customer. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00055 |
| MDR Report Key | 6337316 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-16 |
| Date of Report | 2017-07-12 |
| Date Mfgr Received | 2017-06-16 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2017-02-16 |
| 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 AST-YS07 TEST KIT |
| Generic Name | VITEK? 2 AST-YS07 TEST CARD |
| Product Code | NGZ |
| Date Received | 2017-02-16 |
| Catalog Number | 414967 |
| Lot Number | 2870125203 |
| Device Expiration Date | 2018-03-31 |
| 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 | 2017-02-16 |