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

Model Number	e601
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys troponin t gen 5 stat and elecsys probnp ii stat results for 9 patient samples on a cobas 6000 e601 module.Examples for 2 patients were provided.Patient 1's initial troponin result was 188 ng/l.The repeat result on another e601 module was 483 ng/l.Patient 2's initial probnp result was 116 pg/ml.The repeat result on another e601 module was 543 ng/l.The repeat results were deemed to be correct.The samples were repeated due to an abnormal qc.
Additional Manufacturer Narrative
The elecsys troponin t gen 5 stat reagent lot number was 92446500, and the expiration date is 30-apr-2027.The elecsys probnp ii stat reagent lot number is 88096700, and the expiration date is 31-oct-2026.Qc was within range prior to the event.A field service engineer (fse) determined that the pre-wash sipper mechanism was having intermittent issues and replaced it.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: 50866835
• Report Number: 1823260-2026-03902
• Device Sequence Number: 16131329
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 09/01/2026
• 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