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	03/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 86869600 with an expiration date of 31-oct-2026.Initial service visit: the field service engineer found an issue with the white tip of the sample probe, and he replaced the probe and the sipper tubing.He performed a system volume check, photomultiplier high voltage check, blank cell calibration, and analyzer performance testing.Second service visit: the field service engineer found a loose tube nut at the tube lifter connection and found crystallized residue, indicating minor leakage.He tightened the loose tube nut, inspected all procell flow paths for leaks or contamination, cleaned and checked valves and tubing, cleaned and lubricated all tube lifters, and cleaned the porcell and cleancell aspiration filters.He performed a system prime, conducted an instrument check, and repeated the samples.All results were acceptable and within specifications.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg+beta results from the cobas 6000 e601 module.Sample 1: the initial result was 43.89 miu/ml, and the repeat result was 85.44 miu/ml.After the initial service visit, the customer had further questionable elecsys hcg+beta results.Sample 2: the initial result was 10124 miu/ml, and the repeat result the next day was 16932 miu/ml.Sample 3: the initial result was 48090 miu/ml, and the repeat result the next day was 94281 miu/ml.Sample 4: the initial result was 7512 miu/ml, and the repeat result the next day was 14440 miu/ml.Sample 5: the initial result was 20806 miu/ml, and the repeat result the next day was 35142 miu/ml.The repeat results were believed to be correct and reported outside of the laboratory.
Additional Manufacturer Narrative
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 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: 24793942
• Report Number: 1823260-2026-01310
• Device Sequence Number: 8805369
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 05/08/2026

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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