MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04745868001
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys hbsag ii result from the cobas 6000 core unit for one patient.The initial result was 1.24 coi (reactive).The repeat result was 0.68 coi (non-reactive).The questionable result was not released outside of the laboratory as it did not match the patient's clinical diagnosis.
Additional Manufacturer Narrative
The elecsys hbsag ii reagent lot number is 863863, and the expiration date was not provided.Per product labeling, "all initially reactive or borderline samples should be retested in duplicate using the elecsys hbsag ii." a field service engineer (fse) determined that the measuring cell has been in use for more than 2 years, and the customer does not perform regular lfc (liquid flow cleaning).The fse replaced the measuring cells, resolving the issue.The investigation determined that the service action resolved the issue.

• Brand Name: COBAS 6000 CORE UNIT
• Common Device Name: CLINICAL CHEMISTRY 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: 24914465
• Report Number: 1823260-2026-01486
• Device Sequence Number: 9828252
• Product Code: JJE
• UDI-Device Identifier: 04015630924691
• UDI-Public: 04015630924691
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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 Catalogue Number: 04745868001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2026
• Initial Report FDA Received Date: 04/17/2026
• 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