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 2018-07-20 for CEA ELECSYS 11731629322 manufactured by Roche Diagnostics.
[114705602]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[114705603]
The customer complained of a questionable elecsys cea assay result from 1 patient sample tested on a cobas e 411 immunoassay analyzer. The initial cea result was 9. 38 ng/ml. On (b)(6) 2018 a cea result of 708. 8 ng/ml was obtained from a different pack of reagent. The erroneous result was not released outside of the laboratory. There was no allegation of an adverse event. The customer stated that the original reagent pack had magnetic beads that were frozen which they believed might have caused the erroneous result. The cobas e411 serial number was (b)(4). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02419 |
| MDR Report Key | 7706357 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-20 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-07-04 |
| Date Mfgr Received | 2018-07-07 |
| Date Added to Maude | 2018-07-20 |
| 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 |
| 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 | CEA ELECSYS |
| Generic Name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| Product Code | DHX |
| Date Received | 2018-07-20 |
| Model Number | NA |
| Catalog Number | 11731629322 |
| Lot Number | 244848 |
| 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 | 2018-07-20 |