MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-25 for SENSITITRE manufactured by Trek Diagnostic Systems Ltd..
[1935211]
The trek yeastone mic panel was modified by the manufacturer in (b)(6) 2010 and the company failed to notify us. Applying the old plate well configuration to reading the new plate well format will result in either falsely lower or higher fluconazole mics by one dilution, due to the reconfiguration of the plate wells. This error has the potential of reporting false fluconazole susceptibility, and may lead to incorrect antifungal therapy. Dates of use: (b)(6) 2011. Diagnosis or reason for use: candidemia - candida tropicalis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019597 |
| MDR Report Key | 2006264 |
| Date Received | 2011-02-25 |
| Date of Report | 2011-02-25 |
| Date of Event | 2011-01-14 |
| Date Added to Maude | 2011-03-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSITITRE |
| Generic Name | YEASTONE |
| Product Code | NGZ |
| Date Received | 2011-02-25 |
| Lot Number | B0382 |
| Device Expiration Date | 2012-09-21 |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TREK DIAGNOSTIC SYSTEMS LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-25 |