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

Catalog Number	07649142001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The reagent's lot number is 845550.The expiration date was not provided.The field service representative found that the rinse station nozzle was randomly sticking and a splash of water was on the top of the cuvette.He replaced the gear-pump head, replaced the cuvette/lamp, checked the water/detergent levels, checked the main pump pressure, and rerouted the vacuum tubing to the nozzle.He checked the detergent area and found crystallization on the check valve.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant hemoglobin a1c results for 1 patient sample on a cobas c 513 analyzer.The initial result was 36.60 mmol/mol.The repeated result was 37.20 mmol/mol.On (b)(6) 2025, the sample was repeated, and the results were 35 mmol/mol and 40.20 mmol/mol.
Additional Manufacturer Narrative
A general reagent issue was excluded.The field service representative replaced the reagent probes and performed tests with acceptable results.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
• MDR Report Key: 23478943
• Report Number: 1823260-2025-04513
• Device Sequence Number: 10228263
• 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
• Report Date (Section B): 12/12/2025

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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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