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

Model Number	E601
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hbsag ii results for 3 patient samples on a cobas 6000 e601 module.Sample 1: the initial result was 1.07 coi (reactive), and the repeated result was 0.633 coi (non-reactive).The patient's infection status remained inconclusive.However, the sample was deemed "initially reactive" and was retested.On (b)(6) 2026, the sample was repeated, and the results were 14.07 coi and 13.66 coi (both reactive).Sample 2: on (b)(6) 2026, the initial result was 8.97 coi (reactive), and the repeated results were 0.353 coi (non-reactive) and 0.415 coi (non-reactive).Sample 3: on (b)(6) 2026, the initial result was 19.70 coi (reactive) with a data flag, and the repeated result was 0.600 coi (non-reactive).
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).On (b)(6) 2026, the field service representative performed sample probe adjustments.The investigation is ongoing.

• 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 46250-0457
• MDR Report Key: 24756582
• Report Number: 1823260-2026-01209
• Device Sequence Number: 21107451
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 05/13/2026

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
• Device Lot Number: 863863
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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