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

Catalog Number	05964067001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application lot number is 860395.The field service engineer inspected the module and determined that a torn vacuum tube in one of the nozzles caused the event.He fixed and reseated the vacuum tubing, inspected rinse tubing condition, replaced the sodium hydroxide (naoh) tygon tubing, and verified the fluidic rinse levels and gear pump pressure.He verified the module's performance with qcs.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application assay results from three patient samples tested on the cobas 8000 cobas c 502 module.Patient sample 1 the initial result from the module was 11.0%.The repeat result from another analyzer was 6.3%.The doctor questioned the result, prompting the rerun.The repeat result was deemed correct.Patient sample 2 the initial result from the module was 16.4%.The repeat result from another analyzer was 5.15%.Patient sample 3 the initial result from the module was 10.1%.The repeat result from another analyzer was 5.07%.

• 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: 25049688
• Report Number: 1823260-2026-01702
• Device Sequence Number: 10370229
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 06/08/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/08/2026
• 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