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

Catalog Number	04491777160
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys cea assay, and several other assay results from an unspecified number of patient samples tested on the cobas 6000 e601 (ul) v, with serial number (b)(4).The reporter stated, that the qc was out of range and multiple patient results were flagged.The reporter then ran an assay profile of the evening shift and noted, that the qc for cea was out of range twice.The procell and cleancell were then replaced.The qc was rerun with acceptable results.The reporter pulled an interface report and noticed several low results on multiple assays.The reporter was able to provide two examples of questionable results.The initial results were reported outside of the laboratory.Sample 1: on (b)(6) 2023, the initial result using an aliquoted sample was 63.46 ng/ml.On (b)(6) 2023, the repeat result using the primary tube (after service) was 118.9 ng/ml.Sample 2: the initial result was 0.5 ng/ml.The repeat result was 5.66 ng/ml.The repeat results were deemed correct. .
Additional Manufacturer Narrative
The field service engineer inspected the module and could not find the cause of the event.He tightened the sipper probes.And the customer used the module without any issues.The last calibration performed on 31-mar-2023 was within specifications.Qc 1 was acceptable on the date of the event and after the repeat.Qc 3 had some out-of-range (high) results.The investigation is ongoing.
Additional Manufacturer Narrative
The alarm trace contained multiple "abnormal aspiration" alarms.This can be an indicator of poor sample quality.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS CEA ASSAY
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16877246
• Report Number: 1823260-2023-01519
• Device Sequence Number: 5730718
• Product Code: DHX
• UDI-Device Identifier: 04015630938919
• UDI-Public: 04015630938919
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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 Catalogue Number: 04491777160
• Device Lot Number: 627736
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male