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

Catalog Number	07649142001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tina-quant hemoglobin a1c reagent expiration date was not provided.The cobas c513 analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application results for several patients' samples tested on a cobas c513 analyzer.Discrepant results for two patient samples were provided: patient sample 1 initial result: 6.7 %.Repeat result: 7.3 %.The repeat result of 7.3 % was deemed to be correct.Patient sample 2 initial result: 6.6 %.Repeat result: 7.2 %.The qc failed, prompting the repeat of the samples.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
Medwatch fields d1, d2a, d2b, d4, g1 and g4 were updated.It was noted that the sample probe was contaminated.The sample probe was cleaned.Qc was performed with successful results.The instrument was performing within specifications.Cleaning the sample probe resolved the issue.The investigation did not identify a product problem.The cause of the event was consistent with a contaminated sample probe.

• 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: 23630439
• Report Number: 1823260-2025-04797
• Device Sequence Number: 18715079
• 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
• 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
• Device Lot Number: ASKU
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/24/2025
• 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