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 2016-09-01 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[53729759]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[53729760]
A customer in the (b)(6) reported the occurrence of discrepant ast results (intermediate and/or susceptible) for a (b)(6) survey sample (b)(6) (candida albicans) in association with the vitek 2 ast-ys07 test kit. Fluconazole i/s (mic = 4mg/l). Voriconazole s (mic <= 0. 12mg/l). The expected results were resistant. Fluconazole i/s (mic > 64mg/l). Voriconazole s (mic > 8mg/l). Note: in the final report from (b)(6), fluconazole and voriconazole were not graded since the "levels of concordance with fluconazole (63%) and voriconazole (59%) did not reach the requisite 80% of participants. " the customer repeated testing using the vitek 2 ast-ys07 test kit and obtained susceptible results of <=1mg/l for fluconazole and <=0. 12mg/l for voriconazole. It is unknown if any alternate method was employed to confirm the expected result. There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to any patient's state of health. There is no patient directly associated with the survey sample. Internal biomerieux investigation was conducted. Investigational testing included the following. Vitek 2 yst id test kit confirmed the organism identification to candida albicans. Broth microdilution (bmd): fluconazole mic >64mg/l (r) and voriconazole mic>16mg/l (r). Vitek 2 ast-ys07 test kit (from sda media, customer lot and random lot): customer lot: fluconazole mic =16 mg/l (i) and voriconazole mic = 1 mg/l (s). Random lot: fluconazole mic =16 mg/l (i) and voriconazole mic = 1 mg/l (s). Vitek 2 ast-ys07 test kit (from cos media, customer lot): customer lot: fluconazole mic =<=1 mg/l (s) and voriconazole mic <= 0. 125 mg/l (s). Etest: fluconazole mic >= 256mg/l (r) and voriconazole mic >= 32 mg/l (r). It's possible that the environment of the vitek 2 card and shorter vitek 2 incubation time, compared to other methods (e. G. Bmd, etest), does not provide the optimal environment for this strain. The investigation concluded the (b)(6) survey organism is an atypical strain for vitek 2 testing and that the vitek 2 yeast (yst) identification (id) test kit is performing as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2016-00115 |
| MDR Report Key | 5921065 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-08 |
| Date Mfgr Received | 2016-08-08 |
| Device Manufacturer Date | 2015-09-26 |
| Date Added to Maude | 2016-09-01 |
| 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 | 2016-09-01 |
| Catalog Number | 414967 |
| Lot Number | 287375612 |
| Device Expiration Date | 2017-03-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-09-01 |