MAUDE Adverse Event Report: Roche Diagnostics cobas 6000 e601 module; IMMUNOCHEMISTRY ANALYZER

Model Number	e601
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	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys anti-tg assay results for two patient samples tested on the cobas 6000 e601 module.Patient sample 1 the initial analysis of the patient sample yielded 282.8 iu/ml.The first repeat analysis yielded 20.63 iu/ml.The second repeat analysis yielded 16.85 iu/ml.Patient sample 2 the initial analysis of the patient sample yielded 463.3 iu/ml.The first repeat analysis yielded 18.9 iu/ml.The second repeat analysis yielded 21.5 iu/ml.The repeat results aligned with the patients' expected values.
Additional Manufacturer Narrative
The elecsys anti-tg reagent lot number is 87796701, with an expiration date of 31-aug-2026.The field service engineer (fse) inspected the module and identified the ethylene propylene diene monomer (epdm) packing as the cause of the event.The fse replaced this part and verified the module's performance.The investigation determined that a component failure (epdm packing) had caused the event.The investigation determined that the service actions resolved the issue.

• Brand Name: cobas 6000 e601 module
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50865646
• Report Number: 1823260-2026-03897
• Device Sequence Number: 21188476
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (Y/N): N
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Model Number: e601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• 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
• Patient Sex: Unknown