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 2016-03-14 for ETEST? ITRACONAZOLE 525818 manufactured by Biomerieux, Sa.
[40275478]
A customer in (b)(6) reported having issues with the mic on qc while using; etest itraconazole it 32 ww f100. The results are as follows; both c. Albicans (atcc 90028) and c. Parapsilosis get an mic of 0. 032. There is no evidence/indication of the following: injury or death to a patient, evidence that a patient underwent any unnecessary medical procedure due to the reported event, physician alleging the reported event caused him/her to provide incorrect treatment.
Patient Sequence No: 1, Text Type: D, B5
[47816746]
An internal investigation was initiated due to the report of low mic results with etest itraconazole and two (2) atcc strains: candida parapsilosis atcc 22019 and candida albicans atcc 90028. Results of the internal investigation are as follows: since 2010, there has been only one (1) complaint about this molecule. Inoculation by floating is not within the recommendations of intended use and it is also necessary for antifungals to swabbed twice. Recommendation of package insert: soak a sterile, non-toxic and not too tightly spun swab in the inoculum suspension and remove excess fluid by pressing it against the inside wall of the test tube. Carefully streak the entire agar surface three times, rotating the plate 60 degrees each time to evenly distribute the inoculum. Soak the swab again and repeat the streaking procedure a second time. Alternatively, use retro c80 (rota-plater, biom? Rieux) to efficiently streak the inoculum over the agar surface and then soak the swab again before streaking a second time. Allow excess moisture to be absorbed for approximately 15 to 20 minutes so that the surface is completely dry before applying the etest gradient strips. The conformity of this batch was confirmed with three (3) atcc stains (atcc 90028 - atcc 6258 - atcc 22019). Testing was performed on the customer's strips and the retained samples corresponding to the batch 1003467650 in parallel with another batch as reference. Result- unable to reproduce the customer's observation with the quality control strains.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00053 |
| MDR Report Key | 5498174 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-14 |
| Date of Report | 2016-03-04 |
| Date Mfgr Received | 2016-03-04 |
| Device Manufacturer Date | 2014-09-03 |
| Date Added to Maude | 2016-03-14 |
| 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, SA |
| Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
| Manufacturer City | LA BALME LES GROTTES ISERE, 38390 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? ITRACONAZOLE |
| Generic Name | ETEST? ITRACONAZOLE |
| Product Code | NGZ |
| Date Received | 2016-03-14 |
| Catalog Number | 525818 |
| Lot Number | 1003467650 |
| Device Expiration Date | 2017-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, SA |
| Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE, 38390 FR 38390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-14 |