MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for ELECSYS CA 15-3 II ASSAY CA 15-3 G2 manufactured by Roche Diagnostics.
[134313999]
The investigation did not identify a product problem. The cause of the event could not be determined. There were no corrective/follow-up actions determined. No devices were returned this device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10
[134314000]
This report summarizes 1 malfunction event. Erroneous high results were generated by the cobas 8000 e 602 module. The events involved a total of 2 patients with erroneous results for cobas 8000 e 602 module. The patients' ages were requested but were not provided. The patients' weights were requested but were not provided. The patients' genders were requested but were not provided. The patients' races were requested but were not provided. The patients' ethnicities were requested but were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90035 |
| MDR Report Key | 8281646 |
| Date Received | 2019-01-28 |
| Date Added to Maude | 2019-01-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | SANDHOFFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG), NA 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ELECSYS CA 15-3 II ASSAY |
| Generic Name | TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | MOI |
| Date Received | 2019-01-28 |
| Model Number | CA 15-3 G2 |
| Lot Number | 270343 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |