MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-12 for AZO manufactured by Siemens Diagnostics, Inc..
[2819566]
The colors on the uti test pads did not match any of the colors on the bottles. The wbc pad turned pink and the nitrite pad remained the same. Consumer went to dr and was diagnosed with uti. Amerifit is investigating this complaint pursuant to its internal procedures which included a review of the product release file and retain samples. From the info provided it appears that the consumer may have been comparing the test pads incorrectly to the color chart. The test strips may have been used in a manner not directed in the package insert. The consumer was diagnosed by a health professional with a uti so it could be that nitrites weren't present in the urine at the time the azo test strips were used. We're not able to obtain add'l info on what test(s) were used to diagnose a uti by consumer's health professional. Should add'l info become available, a supplemental report will be filed. Pma/510(k) k960888. Device manufacture date: 04/2008. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026137 |
| MDR Report Key | 2654769 |
| Date Received | 2012-07-12 |
| Date of Report | 2009-09-03 |
| Date of Event | 2009-08-13 |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AZO |
| Generic Name | AZO TEST STRIPS |
| Product Code | CEN |
| Date Received | 2012-07-12 |
| Lot Number | 8D14DA |
| Device Expiration Date | 2010-04-30 |
| 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 |