MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-12 for AZO TEST STRUOS 70021803267-24 manufactured by Siemens Diagnostics.
[2776065]
Pt used two different tests strips and the color didn't change resulting in the device not detecting a uti. Pt was ultimately diagnosed with uti upon visiting her physician. Amerifit is currently reviewing its files for the lot of product noted in this report. It is possible to receive false negatives when this product if not used in accordance with the package insert instructions. The instructions clearly state that after testing twice with negative results, but still showing symptoms, to contact physician. Upon completion of its investigation, amerifit will contact the complainant directly. Amerifit has agreed to refund the purchase price of the product to the pt. Manufacture date: 04/2008. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026136 |
| MDR Report Key | 2654768 |
| Date Received | 2012-07-12 |
| Date of Report | 2009-04-13 |
| Date of Event | 2009-03-02 |
| Date Added to Maude | 2012-07-16 |
| 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 | AZO TEST STRUOS |
| Generic Name | UTI DETECTION (LEUCOCYTES/NITRITES) |
| Product Code | CEN |
| Date Received | 2012-07-12 |
| Catalog Number | 70021803267-24 |
| Lot Number | 8D14D-A |
| Device Expiration Date | 2010-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS DIAGNOSTICS |
| Manufacturer Address | 115 NORWOOD PARK SOUTH NORWOOD MA 02063 US 02063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-12 |