MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964067001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hba1c reagent lot number was 888030.The reagent expiration date was requested, but not provided.The field service engineer determined there was a small tear in rinse station tubing caused by friction against the housing.The damaged part of the tubing was removed and it was re-installed.Washing maintenance was performed to verify fluidic integrity.A cell blank measurement was performed and passed.Precision studies were performed.A hardware performance check was performed and passed.No more leaks were observed.Calibration and controls were acceptable.A review of alarm trace data did not show any relevant alarms.The investigation determined the service actions resolved the issue.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application on a cobas 8000 c 502 module.The initial sample results were questioned by medical staff.The samples were repeated and the repeat results were deemed correct.The first sample initially resulted in an hba1c value of 6.7 % and it repeated as 5.2 %.The second sample initially resulted in an hba1c value of 6.5 % and it repeated as 5.1 %.

• Brand Name: COBAS 8000 COBAS C 502 MODULE
• 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: 25092580
• Report Number: 1823260-2026-01762
• Device Sequence Number: 5079312
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 05964067001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/06/2026
• 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 Age: 5 YR
• Patient Sex: Unknown