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

Catalog Number	07649142001
Medical Device Problem Codes	Imprecision (1307); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) replaced the valves and tubing of the cuvette rinse station.The customer has had no further issues since the last service visit.The fse performed multiple service actions over the course of various visits to the customer site.As several service actions were performed, the specific cause of the event could not be determined.
Additional Manufacturer Narrative
The hba1c reagent lot number and expiration date were not provided.On 27-may-2025, the field service engineer (fse) flushed the sample probe wash station and cleaned the lines to the vacuum tank.All wash stations were cleaned.Calibration and qc were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for hba1c on a cobas c 513 analyzer.The initial result was 58.7 mmol/mol.The repeat result was 35.7 mmol/mol.On (b)(6) 2025, the sample was repeated with a result of 37.4 mmol/mol.
Additional Manufacturer Narrative
Discrepant hba1c results were provided for an additional patient sample (patient 3).The initial result was 48 mmol/mol.The repeat result was 37 mmol/mol.The field service engineer (fse) checked the instrument, replaced the reagent probes, and removed and cleaned the bushing.The investigation is ongoing.
Additional Manufacturer Narrative
The issue was not resolved at the customer site.Discrepant hba1c results were provided for an additional patient sample (patient 2).The initial result was 51 mmol/mol.The sample was repeated due to a delta check.The repeat result was 39 mmol/mol.The investigation is ongoing.

• 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: 22193170
• Report Number: 1823260-2025-01807
• Device Sequence Number: 9189034
• Product Code: JJE
• UDI-Device Identifier: 04015630946327
• UDI-Public: 04015630946327
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/10/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 07/28/2025; 09/25/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/16/2025; 08/18/2025; 10/10/2025
• 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