MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-19 for AZO TEST STRIPS manufactured by Teco Diagnostics.
[111621568]
On 6/4/2018 a mailer was sent to the consumer to return any unused portion of the product. To date the item has not been received by ihealth. Based on the timeline the consumer reported, it appears that he had the urine culture performed the same day as the dipstick, thus there was no delay in treatment and no adverse outcome related to the false negative result. The product insert clearly states the limitations of the test and the need to consult a physician for persistent symptoms. Thus, this consumer did not undergo any adverse experience as a direct result of using the product, and thus there is no relationship between this adverse event and use of the product. Additionally, although the patient denies having a blood culture, he did mention "unspecified blood tests" and was diagnosed with "gram negative bacteremia," a diagnosis that can only be obtained via blood culture. It is likely he had a urine culture at (b)(6)and a blood culture at the hospital as an inpatient.
Patient Sequence No: 1, Text Type: N, H10
[111621569]
This spontaneous report was received from an adult male consumer of unspecified age via telephone on 29-may-2018 with further information obtained via telephone on 30-may-2018. His past and current medical history is significant for diabetes (type ii), hypertension, parathyroidectomy, pacemaker placement, cardiac stents (x2), unspecified heart valve replacements, and carotid endarterectomy. The consumer was a poor historian and was unable to provide precise details of his adverse experience. The consumer used azo test strips one time on (b)(6) 2018 because he was experiencing painful urination, "urination blockage," and "urination leakage. " the strip showed a negative result. He called his physician who suggested using a "different" product. The second product produced a positive result. The consumer went to the emergency room, from where he was admitted to the hospital for five days. He stated that his hospital diagnosis and treatment were for gram negative bacteremia. While hospitalized, he received intravenous antibiotics, and a foley catheter was placed. Tests performed were a transesophageal echocardiogram, another unspecified echocardiogram, an unspecified computed tomography scan, and unspecified bloodwork. Results of these tests were unremarkable. The hospital physician recommended a doppler scan of his carotid arteries, but the consumer refused. He was released from the hospital with a prescription for oral antibiotics. At the time of the telephone contact, the patient was "feeling better. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832216-2018-00001 |
| MDR Report Key | 7616876 |
| Report Source | CONSUMER |
| Date Received | 2018-06-19 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-05-29 |
| Date Added to Maude | 2018-06-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JULIE BAGLEY |
| Manufacturer Street | 55 SEBETHE DR |
| Manufacturer City | CROMELL CT 06416 |
| Manufacturer Country | US |
| Manufacturer Postal | 06416 |
| Manufacturer Phone | 8608941257 |
| Manufacturer G1 | TECO DIAGNOSTICS |
| Manufacturer Street | 1268 NORTH LAKEVIEW AVE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AZO TEST STRIPS |
| Generic Name | AZO TEST STRIPS |
| Product Code | JMT |
| Date Received | 2018-06-19 |
| Lot Number | 18058ASM13 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TECO DIAGNOSTICS |
| Manufacturer Address | 1268 NORTH LAKEVIEW AVE ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-06-19 |