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 2017-10-02 for ELECSYS SYPHILIS 06923348190 manufactured by Roche Diagnostics.
[89575129]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[89575130]
The customer received questionable low syphilis elecsys results for four patient samples when compared to the abbott anti-tg assay. Patient a abbott result was 1. 82 and the syphilis elecsys results were 0. 089 and 0. 088 coi (non-reactive). Patient b abbott result was 4. 51 and the syphilis elecsys results were 0. 568 and 0. 586 coi (non-reactive). Patient c abbott result was 1. 22 and the syphilis elecsys results were 0. 116 and 0. 116 coi (non-reactive). Patient d abbott result was 2. 25 and the syphilis elecsys results were 0. 482 and 0. 497 coi (non-reactive). The samples were submitted for preliminary investigation and were tested using immunoblot and the results were: patient a: negative. Patient b: "cannot discriminate". Patient c: "cannot discriminate". Patient d: "cannot discriminate". Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown. There was no allegation of an adverse event. Information concerning the roche analyzer used by the customer was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02166 |
| MDR Report Key | 6907101 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-02 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-13 |
| Date Added to Maude | 2017-10-02 |
| 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 | 2017-10-02 |
| Model Number | NA |
| Catalog Number | 06923348190 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2017-10-02 |