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.
[134460630]
The investigations did not identify a product problem for both events. The cause of the events could not be determined. There were no follow up/corrective actions for both of the events. 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
[134460631]
This report summarizes 2 malfunction events. Erroneous high results were generated by a cobas 6000 e 601 module and a cobas e 411 immunoassay analyzer. The events involved a total of 2 patients with the following: two erroneous result for elecsys ca 125 ii. One patient's age was (b)(6). The remaining patient's age was requested, but not provided. The patients' weights were requested, but not provided. There were 2 females. The patients' races were requested, but not provided. The patients' ethnicities were requested, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90056 |
| MDR Report Key | 8281246 |
| 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 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 | 319832 |
| 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 |