MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; IMMUNOCHEMISTRY ANALYZER

Catalog Number	08454345001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analyzer serial number was (b)(6).Calibration signals were below the expected range.Qc data showed fluctuating results.Instrument maintenance was last performed on (b)(6) 2023."sample foam detection" and "sample short" alarms occurred on (b)(6) 2023.Instrument performance testing on (b)(6) 2023 failed.On (b)(6) 2023 the field service engineer (fse) replaced the measuring cells, checked the reagent probes, and performed an instrument check.The instrument check passed.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient sample tested for elecsys cea (cea) on a cobas e 801 analytical unit.On (b)(6) 2023 the result from the e801 analyzer in question was 0.99 ng/ml.On (b)(6) 2023 the repeat result on a different e801 analyzer was 0.79 ng/ml.On (b)(6) 2023 the sample was repeated on the e801 analyzer in question with a result of 2.31 ng/ml.The sample was repeated on this analyzer with a result of 1.03 ng/ml.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The cea reagent lot number was 72551902 with an expiration date of 30-sep-2024.No issues were identified during a review of images provided from the sample foam detection camera.Based on the information provided, the investigation determined the event was due to a maintenance issue.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18268827
• Report Number: 1823260-2023-03864
• Device Sequence Number: 17164598
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023
• 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: 09/30/2024
• Device Catalogue Number: 08454345001
• Device Lot Number: 72551902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/20/2023
• 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 Sex: Unknown