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

Catalog Number	07649142001
Medical Device Problem Codes	High Test Results (2457); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reagent issues were excluded as the customer had no further issues, and the correct repeat result was received using the same reagent.The field service engineer (fse) found issues with the components within the cell rinse.The fse replaced valves and confirmed the module was operating within specification.The investigation determined that the issue found by the fse was the root cause of the event.
Event or Problem Description
The initial reporter received questionable tina-quant hemoglobin a1cdx gen.3 result from multiple patient samples tested on the cobas c 513 analyzer.The following are examples of discrepant results: patient sample 1: the initial result was 14.89%.The repeat result was 12.89%.Patient sample 2: the initial result was 26.89%.The repeat result was 5.31%.Patient sample 3: the initial result was 11.01%.The repeat result was 8.10%.The repeat result was deemed correct.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The cobas c513 analyzer commercial system serial number is (b)(6).The field service engineer (fse) inspected the analyzer, replaced the sample probes and suction tubing, checked the horizontal and vertical adjustments of the probes and adjusted the cuvette wash volume.The qcs were performed with acceptable results.The investigation is ongoing.
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 31-oct-2025, new questionable tina-quant hemoglobin a1cdx gen.3 results for three patient samples tested on the cobas c 513 analyzer were reported.Patient sample 4 the initial result from the analyzer was (b)(4).The repeat result from a variant analyzer was (b)(4).Patient sample 5 the initial result from the analyzer was (b)(4).The repeat result from a variant analyzer was (b)(4).Patient sample 6 the initial result from the analyzer was (b)(4).The repeat result from a variant analyzer was (b)(4).

• 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: 23381363
• Report Number: 1823260-2025-04341
• Device Sequence Number: 18322469
• Product Code: JJE
• UDI-Device Identifier: 04015630946327
• UDI-Public: 04015630946327
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 12/11/2025

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
• Device Lot Number: 856360
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 10/31/2025; 11/25/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/24/2025; 12/11/2025
• 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