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

Model Number	E601
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 91168201 with an expiration date of 31-oct-2026.The investigation is ongoing.
Event or Problem Description
There was an allegation of false-negative elecsys syphilis results for 9 patient samples on a cobas 6000 e601 module.Sample 1: the initial result was 0.225 (negative), and the repeated result was 70.91 (positive).Sample 2: the initial result was 0.635 (negative), and the repeated results were 252.9 and 244.8, both interpreted as positive.Sample 3: the initial result was 0.12 (negative), and the repeated results were 33.16 and 31.06, both interpreted as positive.Sample 4: the initial result was 0.28 (negative), and the repeated results were 286.4 and 268.4, both interpreted as positive.Sample 5: the initial result was 0.105 (negative), and the repeated results were 38.2 and 35.34, both interpreted as positive.Sample 6: on april 28, 2026, the initial result was 0.305 (negative), and the repeated result was 403.6 (positive).Sample 7: on april 28, 2026, the initial result was 0.078 (negative), and the repeated result was 2.48 (positive).Sample 8: on april 28, 2026, the initial result was 0.66 (negative), and the repeated result was 375.6 (positive).Sample 9: on april 28, 2026, the initial result was 0.575 (negative), and the repeated result was 453.7 (positive).The unit of measure was not provided.The samples were repeated because the patients were believed to be positive.
Additional Manufacturer Narrative
The field service representative found that a filter for the cleancell bottle was missing, a blown fuse, and the syringe glasses were damaged.He replaced the bead mixer, the sipper needle, and a tube.He performed maintenance, checks, and tests with acceptable results.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: 25115850
• Report Number: 1823260-2026-01790
• Device Sequence Number: 9322004
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 06/18/2026

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: 04/10/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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