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

Model Number E601

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The investigation determined the issue was resolved by the customer recalibrating the assay.

• Brand Name: ELECSYS CEA ASSAY
• Type of Device: 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
• MDR Text Key: 308354220
• Report Number: 1823260-2022-04077
• Device Sequence Number: 1
• Product Code: DHX
• UDI-Device Identifier: 04015630938919
• UDI-Public: 04015630938919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female