MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 513 ANALYZER; CLINICAL CHEMISTRY ANALYZER

Catalog Number	07649142001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 513 analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable tina-quant hemoglobin a1cdx gen.3 results from fifty-three (53) patient samples tested on the cobas c 513 analyzer.The following are examples of discrepant results from five (5) patient samples: patient sample 1 the initial result from the analyzer was 7.5%.The repeat result from another c 513 analyzer was 5.5%.Patient sample 2 the initial result from the analyzer was 10.6%.The repeat result from another c 513 analyzer was 5.2%.Patient sample 3 the initial result from the analyzer was 13.4%.The repeat result from another c 513 analyzer was 8.8%.Patient sample 4 the initial result from the analyzer was 8.5%.The repeat result from another c 513 analyzer was 6.1%.Patient sample 5 the initial result from the analyzer was 9.4%.The repeat result from another c 513 analyzer was 5.6%.The repeat results were deemed correct.
Additional Manufacturer Narrative
Medwatch sections d.Device identification, d.Manufacturer info, g contact office-manufacturing site (continued g1), and medwatch field g4 pma / 510k (premarket numbers) updated.On the field service engineer's (fse) initial service visit, he inspected the analyzer and determined that a damaged solenoid valve and a dirty liquid detection sensor had caused the event.He replaced the solenoid valve, cleaned the sensor, and adjusted the cell levels.He verified the analyzer's performance with instrument checks.On the fse's follow-up service visit, he performed further system verification.The customer did not report any other issues after the service.The investigation determined that the service actions resolved the issue.

• Brand Name: COBAS C 513 ANALYZER
• 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 46250-0457
• MDR Report Key: 23520581
• Report Number: 1823260-2025-04578
• Device Sequence Number: 9732537
• Product Code: JJE
• UDI-Device Identifier: 04015630946327
• UDI-Public: 04015630946327
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160571
• 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): 01/02/2026

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 07649142001
• Device Lot Number: 83943401
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/02/2026
• 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