MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 E601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E601
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The anti-hcv reagent lot number is 90667601 with an expiration date of 31-jul-2026.The hiv combi pt reagent lot number is 86977101 with an expiration date of 30-nov-2026.The qc was acceptable.The field service representative cleaned the tubing system and performed checks, but no issues were found.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
There was an allegation of questionable test results for 4 patient samples on a cobas 6000 e601 module.The affected assays are elecsys anti-hcv ii and elecsys hiv combi pt.Sample 1: the initial anti-hcv result was 1.770 coi (reactive), and the repeated result was 0.647coi (non-reactive).Sample 2: the initial anti-hcv result was 15.03 coi (reactive), and the repeated result was 0.053 coi (non-reactive).Sample 3: the initial anti-hcv result was 7.78 coi (reactive), and the repeated result was 0.074 coi (non-reactive).Sample 4: the initial hiv combi pt result was 4.59 coi (reactive), and the repeated result was 0.17 coi (non-reactive).The samples were repeated due to calibration and quality control issues.The repeated results were believed to be correct.

• 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: 25488134
• Report Number: 1823260-2026-02337
• Device Sequence Number: 16051085
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 06/12/2026

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): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/12/2026
• 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