MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number	07682913001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was requested but was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable troponin t hs assay results for two patient samples tested on a cobas 8000 e 801 module.Sample 1: the tnt result was 17.6 pg/ml.The sample was respun and repeated, giving a result of <5 pg/ml for tnt.The tntst result was <5 pg/ml.Sample 2: the tnt initial result was 12.9 pg/ml.The tnt repeat result was 3.42 pg/ml.The tntst initial result was 4.08 pg/ml.The tntst repeat result was <3 pg/ml.
Additional Manufacturer Narrative
It was provided that the results generated for sample 1 were generated on 22-feb-2026 and the repeat tntst result was 3 pg/ml, specifically.Two additional samples were alleged to have generated questionable results on 06-apr-2026: sample 3: the initial tnt result was 25 pg/ml and the tntst result was 16.4 pg/ml.The repeat tnt result was 16.5 pg/ml and the tntst result was 16.6 pg/ml on the same line.Sample 4: the initial tnt result was 31 pg/ml and the tntst result was 20.8 pg/ml.The repeat tnt result was 26 pg/ml and the tntst result was 21.9 pg/ml on a different line (sn: (b)(6).The qc was within range before the sample measurement.Additionally, a review of the alarm trace did not reveal any alarms.The customer and service maintenance are complete according to the specification.The instrument surfaces and internal lines are adequately clean.The provided data do not indicate an issue with the analyser or the used reagents.The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.

• Brand Name: COBAS 8000 E 801 MODULE
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24619909
• Report Number: 1823260-2026-00951
• Device Sequence Number: 18538307
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 04/30/2026

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: 07682913001
• Device Lot Number: 847376
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 1: FLUOXETINE
• Patient Sex: Unknown