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	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application assay results from one patient's sample tested on the cobas 8000 cobas c 502 module.The initial result from the analyzer was an invalidating data flag.The first repeat result from the analyzer was an invalidating data flag.The customer placed the patient sample tube on a qc rack, as they have a "normal practice" of running the patient samples as qcs when erroneous results are produced.The second repeat result with the patient sample tube in a qc rack is 14.53%.The third and fourth repeat results with the patient sample tube in a qc rack is 9.20% and 9.30%.The fifth repeat result from another laboratory department's sebia capillarys 3 octa analyzer was approximately 5%.This result was deemed correct.No questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
The tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application reagent lot number is 85556501, with an expiration date of 31-aug-2026.The field service engineer investigated the event and identified an issue with the patient sample as the root cause.He inspected the module and verified its performance with qcs, precision checks, and correlation tests.The investigation is ongoing.

• 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: 24651004
• Report Number: 1823260-2026-01023
• Device Sequence Number: 13210700
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/29/2026

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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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