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 2016-04-29 for VITEK? 2 YEAST ANTIMICROBIAL SUSCEPTIBILITY TEST AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[44129435]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[44129436]
A customer in (b)(6) notified biomerieux of discrepant results associated with vitek 2 ast-ys07 test kit involving voriconazole for one isolate, candida albicans, from an external quality control neqas sample (distribution 3789 - strain 2983). (b)(4) expected voriconazole resistant ( mic >8 mg/l r-) but the customer obtained voriconazole sensitive (<=0. 12). Customer results from columbia blood agar were voriconazole mic <=0. 125 mg/l s (twice). There was no patient injury or any adverse event associated with this issue. An internal biomerieux investigation was conducted. Broth microdilution (the reference method for voriconazole development) was performed to determine the intended result, compared with ast-ys07 cards. Two (2) different lots of ast-ys07 cards from sda and cos bmx media. Broth microdilution provided a voriconazole mic >16 mg/l r. On vitek 2, biomerieux obtained results as follows: from sda media and on two (2) ast-ys07 lots: voriconazole mic = 1 s. From cos media and on one (1) ast-ys07 lot: voriconazole mic <=0. 125 s. Vitek 2 voriconazole results (<=0. 125 - 1 mg/l s) are essential agreement errors (gap >2 doubling dilutions with the reference mic). Biomerieux duplicated the customer's results. Complaint history was reviewed with no trends noted. The investigation concluded the discrepancy involved an atypical strain. In addition, in the final report from (b)(4), voriconazole was not graded since the level of concordance voriconazole (59%) did not reach the requisite 80% of participants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2016-00051 |
| MDR Report Key | 5620602 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-29 |
| Date of Report | 2016-04-21 |
| Date Mfgr Received | 2016-04-21 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2016-04-29 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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 ANTIMICROBIAL SUSCEPTIBILITY TEST AST-YS07 TEST KIT |
| Generic Name | VITEK? 2 AST-YS07 CARD |
| Product Code | NGZ |
| Date Received | 2016-04-29 |
| Catalog Number | 414967 |
| Lot Number | 287368220 |
| Device Expiration Date | 2017-01-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-04-29 |