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 2016-09-14 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[54694575]
Patient Sequence No: 1, Text Type: N, H10
[54694576]
A customer in (b)(6) reported the occurrence of a false susceptible fluconazole result for candida albicans in association with the vitek? 2 ast-ys07 test kit. Etest fluconazole provided a resistant result. Repeat testing obtained the same respective results. The customer reports a delay in reporting due to the additional testing performed. The patient was treated with a different antimycoticum. The customer sent the patient strain to a reference laboratory. The reference laboratory obtained results of resistant to fluconazole (test method unknown), confirming the vitek? 2 ast-ys07 result to be discrepant. 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. Internal biom? Rieux investigation will be conducted.
Patient Sequence No: 1, Text Type: D, B5
[66181996]
A biomerieux investigation was initiated due to a false susceptible fluconazole result on the ast-ys07 card for a candida albicans isolate, compared to etest? And reference lab results (resistant). The customer also observed the same issue on voriconazole. The reference method was performed to determine the intended results for fluconazole and voriconazole bmd (broth microdilution), compared with vitek? 2 (v6. 01) and ast-ys07 cards. Category interpretations based on vitek? 2 breakpoints were: fluconazole: s/=64. Voriconazole: s/=4. Two different lots of ast- ys07 cards were tested: the customer lot 287394320 and a random lot 287389420. Test results obtained with bmd: - fluconazole reference mic >64mg/l resistant. -voriconazole reference mic>16 mg/l resistant. Results confirmed those obtained by the reference institute. On vitek? 2, the results obtained on both lots tested were flu mic <= 1mg/l s and vrc mic <=0. 125mg/l s. The investigation duplicated the customer results. The investigation concluded the submitted isolate has an atypical biochemical profile.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00122 |
| MDR Report Key | 5949551 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-14 |
| Date of Report | 2017-01-30 |
| Date Mfgr Received | 2017-01-03 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2016-09-14 |
| 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 | 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 AST-YS07 TEST KIT |
| Generic Name | VITEK? 2 AST-YS07 TEST KIT |
| Product Code | NGZ |
| Date Received | 2016-09-14 |
| Catalog Number | 414967 |
| Lot Number | 287394320 |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-09-14 |