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 STRIPS manufactured by Siemens Diagnostics, Inc..
[17560856]
Pt used test at home and received a negative result. Went to dr who diagnosed uti. Pt tried test at home again and still received a negative result. Amerifit will investigate this complaint pursuant to its internal sop's. There are instances when a negative result may occur if the device is not used properly or if the pt doesn't cleanse properly before using the test. Medications may interfere with actual results and some pts bodies do not always produce nitrites when an uti occurs. In addition, the device in question tests for nitrates and leukocytes. There are uti's that can be caused by other bacteria that would not cause a positive result for either measured component. Should add'l info become available that is important to its investigation of this complaint, an updated report will be filed with fda. Amerifit has provided the pt with replacement product at their request. Manufacture date: 07/2008. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026138 |
| MDR Report Key | 2654770 |
| Date Received | 2012-07-12 |
| Date of Report | 2009-06-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AZO TEST STRIPS |
| Generic Name | URINARY TRACT INFECTION TEST |
| Product Code | CEN |
| Date Received | 2012-07-12 |
| Lot Number | 8G01D-A-035 |
| Device Expiration Date | 2010-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS DIAGNOSTICS, INC. |
| Manufacturer Address | 115 NORWOOD PARK SOUTH NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-12 |