MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-27 for ELECSYS CEA ASSAY 11731629160 manufactured by Roche Diagnostics.
[118563492]
Patient Sequence No: 1, Text Type: N, H10
[118563493]
The customer complained of discrepant elecsys cea assay results for 3 patient samples on a cobas e 411 immunoassay analyzer serial number (b)(4). For patient 1 the initial cea result was 36. 2 ng/ml and the repeat result was 25. 6 ng/ml on the e 411. The sample was sent to a different laboratory. The cea result was 63. 5 ng/ml on the abbott architect instrument and was reported outside of the laboratory. On (b)(6) 2018, the customer changed the reagent pack and recalibrated. The sample was repeated and the cea results were 50. 9 ng/ml and 50. 7 ng/ml. For patient 2 on (b)(6) 2018, the initial cea result was 90 ng/ml and the repeat result was 70 ng/ml on the e 411. The cea result was 200 ng/ml in a different laboratory with the abbott architect. For patient 3 on (b)(6) 2018, the initial cea result was 89 ng/ml and the repeat result was 90 ng/ml on the e 411. The cea result was 400 ng/ml in a different laboratory with the abbott architect. No erroneous results were reported outside of the laboratory. There was no adverse event. The field service engineer(fse) ran a performance test that failed. The fse performed an adjustment and an initial cell blank. The calibration and qc were acceptable with new reagent. The initial investigation determined that prior to (b)(6) 2018 the customer was not using the recommended calibration frequency. The initial investigation determined that the qc was acceptable based on the provided qc data. Based on a review of worldwide data of qc recovery for the reagent/calibrator lot combination used by the customer, no reagent issue was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02882 |
| MDR Report Key | 7818983 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-27 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-08-27 |
| 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 | ELECSYS CEA ASSAY |
| Generic Name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
| Product Code | DHX |
| Date Received | 2018-08-27 |
| Model Number | NA |
| Catalog Number | 11731629160 |
| Lot Number | 28657405 |
| Device Expiration Date | 2019-03-31 |
| 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 | 2018-08-27 |