MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-19 for VITEK 2 AST-YS05 TEST KIT 411945 manufactured by Biom?rieux, Inc..
[20755323]
A customer in the united states contacted biom? Rieux to report a false susceptible fluconazole result (mic = 4) for a candida glabrata organism on the vitek? 2 ast-ys05 test kit (ref 411945, lot 285346710, expiry 11jun2016). The result was reported to the treating physician. The patient isolate was sent to a reference laboratory (arup) for testing. The reference laboratory obtained a resistant result (mic = 16) for fluconazole via broth micro-dilution (bmd). The physician claims treatment failure and delay to receive appropriate treatment >24 hours. Patient therapy was modified once the result from the reference laboratory was received. Biom? Rieux has requested culture submittal for internal testing.
Patient Sequence No: 1, Text Type: D, B5
[20882941]
Device not received by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[34457464]
Two candida glabrata isolates were submitted by the customer to biom? Rieux for evaluation. The organism identification of the isolates was confirmed (candida glabrata) and fluconazole testing included two test kits from the same lot of ast-ys05 as that tested by the customer and two test kits from a random lot. Also tested was broth microdilution (bmd), the reference method for fluconazole. Category calls for all testing was determined using the vitek? 2 breakpoints: <=8 s, 16-32 i, >=64 r. Isolate #1: susceptible mics = 2 were obtained from the four ast- ys05 test kits; bmd gave a susceptible mic = 1. Isolate #2: susceptible mics = 2 were obtained from the customer's lot of ast-ys05 cards and from the random lot, susceptible mics = 2 and 4 were obtained. Bmd gave a susceptible mic = 2. Based on the results of the investigation testing, the vitekc 2 ast-ys05 test kits are performing as expected and within performance claims. The customer's lack of correlation between vitekv 2 and bmd methods could not be duplicated. The 2008 clsi m27-a3 and the 2012 m27-s4, reference method for broth dilution antifungal susceptibility testing of yeast, contains a note which states "when an isolate is identified as candida glabrata and the mic is <=32, it should be considered if fluconazole is appropriate in the specific clinical context. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2015-00005 |
| MDR Report Key | 4780357 |
| Report Source | 05,06 |
| Date Received | 2015-05-19 |
| Date of Report | 2015-05-12 |
| Date of Event | 2015-05-12 |
| Date Mfgr Received | 2015-05-12 |
| Device Manufacturer Date | 2014-12-11 |
| Date Added to Maude | 2015-05-19 |
| 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 | 0 |
| Event Location | 0 |
| 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 | BIOM |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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-YS05 TEST KIT |
| Generic Name | VITEK 2 AST-YS05 TEST KIT |
| Product Code | NGZ |
| Date Received | 2015-05-19 |
| Catalog Number | 411945 |
| Lot Number | 285346710 |
| Device Expiration Date | 2016-06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX, INC. |
| Manufacturer Address | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-19 |