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 2019-05-07 for COMBUR 5-TEST HC 10 STR. 11896954176 manufactured by Roche Diagnostics.
[144274314]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[144274315]
The initial reporter questioned positive nitrite and leucocytes results for 1 patient tested with urine on the combur-5 test hc test strip. The result for nitrite is a reportable malfunction. The nitrite result was "positive" on the combur-5 test strip. The result from an unknown device in surgery was "negative. " no specific event details or results could be provided by the reporter. The "positive" results were reported to the patient or medical personnel. There was no allegation that an adverse event occurred. The test strips were requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01713 |
| MDR Report Key | 8585826 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-07 |
| Date of Report | 2019-07-03 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-04-16 |
| Date Added to Maude | 2019-05-07 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 5-TEST HC 10 STR. |
| Generic Name | URINE TEST STRIPS |
| Product Code | JIL |
| Date Received | 2019-05-07 |
| Returned To Mfg | 2019-05-07 |
| Model Number | NA |
| Catalog Number | 11896954176 |
| Lot Number | 35021301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-05-07 |