MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-04 for COMBUR-10-M 100 STR 11379208173 manufactured by Roche Diagnostics.
[177854831]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[177854832]
The initial reporter stated they received discrepant nitrite results for one patient sample tested with combur 10 m test strips on a cobas u 411 analyzer. The reporter suspects the uroberry medication the patient was taking interfered with the test method. The sample initially resulted with a positive nitrite value accompanied by a data flag when tested on the u 411 analyzer. The sample was repeated on the u 411 analyzer, resulting with a negative nitrite value. The sample was also tested manually using a competitor urine test strip (spinreact) and the nitrite result was positive. The u 411 analyzer serial number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2020-00286 |
| MDR Report Key | 9664089 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-04 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMBUR-10-M 100 STR |
| Generic Name | URINE TEST STRIPS |
| Product Code | JMT |
| Date Received | 2020-02-04 |
| Model Number | COMBUR-10-M |
| Catalog Number | 11379208173 |
| Lot Number | 41516505 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |