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 2018-11-26 for ELECSYS CEA ASSAY 11731629322 manufactured by Roche Diagnostics.
[129186838]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129186839]
The customer received a questionable low elecsys cea assay results for one patient sample from two cobas 6000 e 601 modules. The serial numbers were (b)(4). It was unclear which analyzer generated which specific result. The initial result was less than 1. 0 ug/l and was reported outside of the laboratory. The physician did not believe the result and the sample was repeated. The repeat results were 0. 267 ug/l, 17. 69 ug/l, and 17. 77 ug/l. There was no allegation of an adverse event. The field service representative checked the instruments and performed a system volume check. On cobas e601 serial number (b)(4), he found the branch block had a slight leak and he replaced the branch block and pinch tube. He performed a sipper purge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04480 |
| MDR Report Key | 8103492 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-26 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-11-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 CEA ASSAY |
| Generic Name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| Product Code | DHX |
| Date Received | 2018-11-26 |
| Model Number | NA |
| Catalog Number | 11731629322 |
| Lot Number | 355404 |
| 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 | 2018-11-26 |