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 2016-10-28 for VITEK? 2 AST-YS07 TEST KIT 414967 manufactured by Biomerieux, Inc.
[58824369]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[58824370]
A customer in (b)(6) reported the occurrence of false susceptible fluconazole (mic <=1 mg/l) for candida albicans (b)(6) sample in association with the vitek 2 ast-ys07 test kit. Repeat test obtained the same result. As evident from the report from (b)(6), approximately 50% of the laboratories involved in the survey using automated susceptibility testing systems reported the candida albicans strain as susceptible for fluconazole, itraconazole, and voriconazole. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the survey sample. Culture submittal was requested by biomerieux for internal investigation. Biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[68240503]
A customer in denmark reported the occurrence of false susceptible fluconazole (mic <=1 mg/l) for candida albicans neqas sample in association with the vitek? 2 ast-ys07 test kit. An internal investigation was performed. This investigation was initiated due to discrepant results on three (3) drugs ( amphoterin b, fluconazole, voriconazole)on ast-ys07 card for one isolate candida albicans, from an external quality control called neqas (distribution 3789-strain 2938). Neqas information/expected results: -amphotericin b mic = 0. 125mg/l s. -fluconazole mic >6 4 mg/l r. . -voriconazole mic >8 mg/l r. Please note: in the final report from neqas, 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". Biom? Rieux performed the reference methods to determine the intended results for amphotericin b (broth macrodiution), and for fluconazole and voriconazole (both microdilution), compared to vitek? 2 ast-ys07 cards. Amphotericin b reference mic= 0. 5mg/l s, fluconazole ref mic >64 mg/l r and voriconazole ref mic >16 mg/l r were obtained. On vitek? 2, the following were obtained: -from sda media and on 2 ast-ys07 lots: ab mic =8 r (>=16 r) - flu mic =16 i and vrc mic= 1s. -from cos media and on 1 ast-ys07 lot: ab mic =8 r - flu mic <=1s and vrc mic<=0. 125 s. Vitek? 2 amphotericin b results (8 - >=16 mg/l r) are in essential agreement error (gap >2 doubling dilutions with the reference mic) which lead to a major error. Vitek? 2 fluconazole results (<=1 mg/l s) and voriconazole results (<=0. 125- 1 mg/l s) are in essential agreement errors (gap >2 doubling dilutions with the reference mic) which lead to a very major error for each drug. Biom? Rieux duplicated the non-reproducible results and the discrepancies with expected neqas values. The investigation concluded that the isolate exhibits atypical growth behavior.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00160 |
| MDR Report Key | 6064646 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-28 |
| Date of Report | 2017-02-17 |
| Date Mfgr Received | 2016-04-26 |
| Date Added to Maude | 2016-10-28 |
| 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 | 2016-10-28 |
| Catalog Number | 414967 |
| 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 | 2016-10-28 |