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

Catalog Number	08454345001
Medical Device Problem Codes	Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tropinin reagent lot number and expiration date were not provided.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tested with elecsys troponin assay on a cobas e801 immunoassay analyzer.Initial result: 5.39.1st repeat result: 10.030.2nd repeat result: 6.19.The units of measurement were not provided.
Additional Manufacturer Narrative
The medical device problem code was updated.The customer alleged discrepant results for an additional patient's sample tested on line 2 compared to line 1.Line 2: initial result: 8.72 1st repeat result: 12.10 2nd repeat result: 7.87.Line 1: 3rd repeat result: 5.38 4th repeat result: 5.46.The getlog and sample foam detection images from line 2 were requested but not provided.A recent onsite investigation at the customer's laboratory identified issues with the plasma serum tube samples, notably the formation of a film and particles on the sample surface.The cause of the event was consistent with an issue in the sample quality.
Additional Manufacturer Narrative
The customer alleged discrepant results for an additional patient's sample tested on (b)(6) 2023: initial result: 5.39 pg/ml.1st repeat result: 4.94 pg/ml.2nd repeat result: 10.31 pg/ml.3rd repeat result: 6.19 pg/ml.The getlog data was provided covering the period from (b)(6) 2023 1:10 am until (b)(6) 2023 11:29 pm.According to the getlog, the questionable results were not measured from the same sample container and occurred from different positions in the rack.Sample foam detection (sfd) images were provided and showed that the sample in question had a film and particles on the surface.The investigation did not identify a product problem.The cause was due to issues with the plasma tube, lithium heparin (spray coated) used by the customer, leading to an issue in the sample quality.

• 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
• MDR Report Key: 18314342
• Report Number: 1823260-2023-03961
• Device Sequence Number: 6267733
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 02/02/2024

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: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 01/15/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/05/2024; 02/02/2024
• 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