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

Catalog Number	07649142001
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The a1cx3 reagent lot number was 819978 with an expiration date of 31-jan-2026.Calibration was last performed on (b)(6) 2026 with no issues.Qc was acceptable.There is no indication of a reagent performance issue.No issues were observed during a review of the alarm trace data.The field service engineer (fse) observed alkaline splashing at a nozzle and adjusted the worn needle valve.The probe and drain valves were replaced.Monthly maintenance activities were performed, and the system passed all instrument checks.The investigation determined that the issue found by the fse (worn needle valve) was the root cause of the event.
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for tina-quant hemoglobin a1cdx gen.3 (a1cx3) on a cobas c 513 analyzer.The initial result was 10.5%.The sample was repeated twice, with results of 6.5% and 6.4%.The high result in question was not reported outside of the laboratory.The customer repeated the sample as the patient "never had a high result before." the repeat results were believed to be correct.

• 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
• MDR Report Key: 24276186
• Report Number: 1823260-2026-00419
• Device Sequence Number: 21313925
• Product Code: JJE
• UDI-Device Identifier: 04015630946327
• UDI-Public: 04015630946327
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 07649142001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/06/2026
• 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 Sex: Unknown