MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-05-24 for COAGUCHEK S SYSTEM 3116247 manufactured by Roche Diagnostics.
[458945]
Discrepant results when compared to a lab. The reported device result was 7. 0 inr. The corresponding lab result reported was 3. 9 inr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2006-02483 |
| MDR Report Key | 719808 |
| Report Source | 06 |
| Date Received | 2006-05-24 |
| Date of Report | 2006-05-11 |
| Date of Event | 2006-05-10 |
| Date Mfgr Received | 2006-05-11 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-05-31 |
| 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 | 0 |
| Manufacturer Contact | CHRISTOF LITTWITZ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAGUCHEK S SYSTEM |
| Generic Name | PROTHROMBIN TIME TEST STRIPS |
| Product Code | GJG |
| Date Received | 2006-05-24 |
| Model Number | NA |
| Catalog Number | 3116247 |
| Lot Number | 235A |
| ID Number | NA |
| Device Expiration Date | 2007-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 708876 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | COAGUCHEK PT TEST STRIPS |
| Baseline Generic Name | COAGUCHEK TEST STRIPS |
| Baseline Model No | NA |
| Baseline Catalog No | 3116247 |
| Baseline ID | NA |
| Baseline Device Family | COAGUCHEK |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K974569 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-24 |