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 125 II CA 125 G2 manufactured by Roche Diagnostics.
[134458671]
The investigation is ongoing. The follow up/corrective actions were that the sample was requested for investigation. 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
[134458672]
This report summarizes 1 malfunction event. Non-reproducible results were generated by the cobas 6000 e 601 module. The event involved a total of 1 patient with non-reproducible results for the elecsys ca 125 ii assay. The patient age was (b)(6). The patient weight was requested, but was not provided. The patient gender was female. The patient's race was requested, but was not provided. The patient's ethnicity was requested, but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90026 |
| MDR Report Key | 8280763 |
| 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 | 0 |
| Product Problem Flag | 0 |
| 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 125 II |
| Generic Name | TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) |
| Product Code | LTK |
| Date Received | 2019-01-28 |
| Model Number | CA 125 G2 |
| Lot Number | 34951403 |
| Device Availability | * |
| Device Age | DA |
| 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 |