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

Model Number	E601
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable cea elecsys result from cobas 6000 e601 module serial number (b)(4).The initial result was 0.97 ng/ml and was reported outside of the laboratory.The qc performed afterward was not acceptable.The customer recalibrated the assay and ran qc which was acceptable.The customer then repeated the sample.The repeat result was 1.54 ng/ml and was deemed correct.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the issue was resolved by the customer recalibrating the assay.

• 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: 16004402
• Report Number: 1823260-2022-04077
• Device Sequence Number: 14111826
• 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): Unknown
• 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): 01/13/2023
• 2 Devices were Involved in the Event: 1 2

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: 08/31/2023
• Device Model Number: E601
• Device Catalogue Number: 04491777160
• Device Lot Number: 62773601
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/13/2023
• 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: 57 YR
• Patient Sex: Female