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 2018-02-14 for ELECSYS CA 15-3 II ASSAY 03045838122 manufactured by Roche Diagnostics.
[100282730]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[100282731]
The customer received a questionable low elecsys ca 15-3 ii assay result for one patient sample from a cobas 8000 e 602 module. The serial number was requested but was not provided. The result was 32. 9 ui/ml and was reported outside of the laboratory. The result from a beckman analyzer was 205 ui/ml. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00437 |
| MDR Report Key | 7270367 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-21 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2018-01-29 |
| Date Added to Maude | 2018-02-14 |
| 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 CA 15-3 II ASSAY |
| Generic Name | TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | MOI |
| Date Received | 2018-02-14 |
| Model Number | NA |
| Catalog Number | 03045838122 |
| Lot Number | 20990000 |
| 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 | 2018-02-14 |