MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for ELECSYS SYPHILIS manufactured by Roche Diagnostics.
[143417160]
The investigation stated since the sample could not be provided, the investigation could not be completed. The investigation did not identify a product problem. The cause of the event could not be determined. Assays from different manufacturers can generate different results due to the different antigens used for different treponemal tests. The follow up/corrective action for this event was that the sample was requested for investigation but could not be provided. 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
[143417161]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90130 |
| MDR Report Key | 8549725 |
| Date Received | 2019-04-25 |
| Date Added to Maude | 2019-04-25 |
| 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 SYPHILIS |
| Generic Name | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM |
| Product Code | LIP |
| Date Received | 2019-04-25 |
| Model Number | SYPHILIS |
| Lot Number | 33880200 |
| 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 | 2019-04-25 |