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 2017-12-07 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[95764192]
A customer from (b)(6) reported to biom? Rieux a false susceptible fluconazole result for a candida albicans strain from a patient blood culture sample, in association with the vitek? 2 ast-ys07 test kit. The customer reported the initial fluconazole result with the ast-ys07 card was susceptible (mic =4 mg/l). The strain was sent to a reference lab and the result was resistant (mic>= 64? G/ml) for fluconazole. There was no retest performed on the ast-ys07 card. The customer stated the false susceptible result was reported to the physician, was then corrected following lab reports from the reference lab. 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. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00435 |
| MDR Report Key | 7096329 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-07 |
| Date of Report | 2018-05-14 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2017-03-06 |
| Date Added to Maude | 2017-12-07 |
| 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 KIT |
| Product Code | NGZ |
| Date Received | 2017-12-07 |
| Catalog Number | 414967 |
| Lot Number | 2870283203 |
| ID Number | 03573026426873 |
| Device Expiration Date | 2018-09-05 |
| 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 | 2017-12-07 |