MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-05-14 for ELECSYS SYPHILIS 06923348190 manufactured by Roche Diagnostics.
[108724431]
Unique identifier (udi)# (b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[108724432]
The customer complained of a (b)(6) result for 1 patient sample tested on a cobas e 411 immunoassay analyzer compared to other test methods and the patient's clinical symptoms. The initial (b)(6) result from the cobas e411 was (b)(6) and then was (b)(6) tested with treponema pallidum particle agglutination assay (tppa). The sample was then retested on a cobas e411 with a (b)(6) result. The rapid plasma reagin (rpr) result for the sample was (b)(6). The sample was then again tested using tppa and was (b)(6). The sample was also tested on an abbott system with a weak (b)(6) result. The result from a colloidal gold test strip was also a strong (b)(6). (b)(6) results of (b)(6) were provided, but it was not known which specific results were the initial or the repeat result. The customer stated the patient had a history of exposure and was considered a high risk. Along with the clinical symptoms of the patient, skin chancre, the patient was confirmed positive for syphilis. The cobas e411 serial number was (b)(4). Qc results on the cobas e411 were good. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01486 |
| MDR Report Key | 7511123 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-14 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-04-28 |
| Date Mfgr Received | 2018-04-28 |
| Date Added to Maude | 2018-05-14 |
| 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 | 3 |
| Manufacturer Contact | NA 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 | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS SYPHILIS |
| Generic Name | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM |
| Product Code | LIP |
| Date Received | 2018-05-14 |
| Model Number | NA |
| Catalog Number | 06923348190 |
| Lot Number | 277571 |
| ID Number | NA |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-14 |