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 2017-03-28 for CEA ELECSYS 11731629322 manufactured by Roche Diagnostics.
[71055423]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[71055424]
The customer received questionable results for one patient using the elecsys cea assay on an unspecified cobas elecsys system. The customer inquired about published literature that described the difference between a true zero result and a false zero result in immunology testing. The customer then provided results. The initial result was <0. 2 ng/ml. The repeat result was 70 ng/ml which was considered correct. It is unknown whether these results were reported to medical personnel. The customer would not provide any additional information. There was no allegation of an adverse event with the patient. The elecsys analyzer information was not provided. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Possible root causes for this event may be sample quality and insufficient maintenance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00655 |
| MDR Report Key | 6439977 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-28 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-06 |
| Date Added to Maude | 2017-03-28 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2017-03-28 |
| Model Number | NA |
| Catalog Number | 11731629322 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-03-28 |