MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CEA ASSAY; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Catalog Number	11731629160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The customer is not using the required rack adapters when processing patient samples.The customer is no using the appropriate length of time for centrifugation.Calibration data is within the acceptable range.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CEA ASSAY
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7818983
• Report Number: 1823260-2018-02882
• Device Sequence Number: 11371150
• Product Code: DHX
• UDI-Device Identifier: 04015630938766
• UDI-Public: 04015630938766
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 11731629160
• Device Lot Number: 28657405
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1