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 2018-02-28 for ELECSYS SYPHILIS 06923348190 manufactured by Roche Diagnostics.
[101578838]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101578839]
The customer stated that they received an erroneous result for one patient sample tested for (b)(6) on a cobas 8000 e 801 module (e801). The erroneous result was not reported outside of the laboratory. The sample was tested on the e801 analyzer, resulting as 0. 1 coi ((b)(6)). The sample was also tested using the mediease tpla method on a cobas 6000 c (501) module, resulting as 49. 0 t. U. ((b)(6)). The sample also resulted with values of 40. 0 t. U. And 29. 0 t. U. When tested with the mediease tpsa method. The sample had an rpr value of 0. 3. No units of measure were provided for the rpr value. No adverse events were alleged to have occurred with the patient. The serial number of the e801 analyzer was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00610 |
| MDR Report Key | 7302336 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-28 |
| Date of Report | 2018-03-30 |
| Date of Event | 2018-02-09 |
| Date Mfgr Received | 2018-02-09 |
| Date Added to Maude | 2018-02-28 |
| 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 | 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 | 2018-02-28 |
| Model Number | NA |
| Catalog Number | 06923348190 |
| Lot Number | 247710 |
| 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 | 2018-02-28 |