MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-05-17 for CHEMSTRIP 2 GP 200743 manufactured by Roche Diagnostics.
[364094]
Pt has been testing with suspect test strips for past 1-2 weeks. Each test, protein result was negative. Pt began to retain water and was edematous. Went to the doctor and protein on doctor's scale was a three (one being the least amount, four being the greatest amount). Pt went home from doctor and tested urine on suspect test strips and protein was negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2004-00338 |
| MDR Report Key | 525838 |
| Report Source | 04 |
| Date Received | 2004-05-17 |
| Date of Report | 2004-05-07 |
| Date of Event | 2004-05-07 |
| Date Mfgr Received | 2004-05-07 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2004-05-21 |
| 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 | DEBARA REESE |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213857 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHEMSTRIP 2 GP |
| Generic Name | URINE TEST STRIPS |
| Product Code | JIR |
| Date Received | 2004-05-17 |
| Model Number | NA |
| Catalog Number | 200743 |
| Lot Number | 28881243 |
| ID Number | NA |
| Device Expiration Date | 2005-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 514977 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 116 SANDHOFER STR. MANNHEIM GM |
| Baseline Brand Name | CHEMSTRIP 2 GP |
| Baseline Generic Name | URINE TEST STRIPS |
| Baseline Model No | NA |
| Baseline Catalog No | 200743 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-05-17 |