MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-09-25 for REFLOTRON GPT (ALT) 745138 manufactured by Roche Diagnostics.
[15610650]
The reporter called and alleged discrepant results on the device when compared to a lab for gpt. Controls were reported as being in range and the site failed their proficiency test and decided to do lab comparisons. The comparisons were done whole blood to serum and then serum to serum. The reported device/lab results were 11. 4/12. 0/26. 0, 8. 08/8. 03/18. 0, 9. 44/9. 56/22. 0, 14. 4/14. 2/31. 0 and 9. 66/9. 29/19. 0. The device was replaced and requested to be returned for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2006-05358 |
| MDR Report Key | 870187 |
| Report Source | 06 |
| Date Received | 2006-09-25 |
| Date of Report | 2006-09-12 |
| Date of Event | 2006-09-11 |
| Date Mfgr Received | 2006-09-12 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2007-06-26 |
| 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 | FERN DELACROIX |
| Manufacturer Street | 9115 HAGUE RD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217494 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 |
| Manufacturer City | MANNHEIM 68298 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68298 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLOTRON GPT (ALT) |
| Generic Name | CLINICAL CHEMISTRY TEST STRIP |
| Product Code | CKD |
| Date Received | 2006-09-25 |
| Model Number | NA |
| Catalog Number | 745138 |
| Lot Number | 23719632 |
| ID Number | NA |
| Device Expiration Date | 2007-08-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 851069 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | * INDIANAPOLIS IN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-25 |