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

Catalog Number	07649142001
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 801755.The expiration date was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable hba1c results for approximately 25 patient samples on a cobas c 513 analyzer.Five examples of patient sample results were provided.Patient 1: the initial result was 5.83%, and the repeated result was 11.93%.Patient 2: the initial result was 5.07%, and the repeated result was 6.68%.Patient 3: the initial result was 6.15%, and the repeated result was 5.11%.Patient 4: the initial result was 6.38%, and the repeated result was 5.44%.Patient 5: the initial result was 10.4%, and the repeated result was 7.19%.The samples were repeated because the clinician questioned the results.The repeated results were obtained on another module and were believed to be correct.
Additional Manufacturer Narrative
The field service engineer found an issue with the solenoid valve assembly, causing the probe washes to be stopped and an issue with the wash stations for all probes.He noted the analyzer was covered in concrete dust.He cleaned the valves and adjusters, replaced the reagent probes, and performed adjustments for all of the probes.He checked the cuvette levels for proper adjustments, ran an instrument check, followed by calibration and qc, which all passed.The analyzer alarm trace contained multiple low reagent level alarms and other conspicuous alarms.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: 22034683
• Report Number: 1823260-2025-01511
• Device Sequence Number: 8778734
• Product Code: JJE
• UDI-Device Identifier: 04015630946327
• UDI-Public: 04015630946327
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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