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 2016-07-26 for VITEK? 2 AST-YS07 414967 manufactured by Biomerieux, Inc.
[50437109]
A customer in (b)(6) notified biomerieux of a discrepant result with the vitek 2 ast-ys07 (reference 414967). The customer reports using a yst card in which the organism, c. Parapsilosis, was identified; however, when performing the antibiotic susceptibility test a discrepancy occurred with the drug fluconazole. Based on the information provided, there was no adverse events, negative patient impact or delay in results. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[68239060]
A biomerieux internal investigation was conducted for a false susceptible fluconazole result on the vitek? 2 ast-ys07 card for an external quality control isolate, candida orthopsilosis, which is not a claimed species for the vitek? 2. The external quality control report stated the intended result for fluconazole was resistant, and the fluconazole alternate testing results using the biomerieux etest? Method were: -lab 1: mic =1,5 mg/l presence of macro colonies which may indicate hetero-resistance. -lab 2: mic =12mg/l resistant. The reference bmd (broth micro dilution) method was performed to determine the intended result for fluconazole compared with vitek? 2 ast-ys07 cards. The result for bmd was mic = 2mg/l (susceptible). The customer lot and a random lot of ast-ys07 cards were tested with the vitek? 2 and the result of <=1mg/l (susceptible) was obtained for both lots, duplicating the customer results. With vitek? 2, the mic of 1 mg/l is in essential agreement with the reference mic (2mg/l s, bmd) within 1 doubling dilution, with no category error. The category interpretations based on vitek? 2 breakpoints claimed for fluconazole were: s /=64. The results observed in-house (no presence of macrocolonies no heteroresistance observed), correlate with the external quality control reference results from lab 1 (1,5mg/l ) but not with lab 2 (12mg/l). The alternative method etest? Fluconazole (fl) result was mic =1mg/l (susceptible). The investigation concluded that the ast-ys07 cards are performing as expected. No further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00078 |
| MDR Report Key | 5822208 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-07-26 |
| Date of Report | 2017-02-09 |
| Date Mfgr Received | 2017-01-12 |
| Date Added to Maude | 2016-07-26 |
| 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 |
| Generic Name | VITEK? 2 AST-YS07 |
| Product Code | NGZ |
| Date Received | 2016-07-26 |
| Catalog Number | 414967 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-07-26 |