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

Catalog Number	07649142001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hba1c reagent lot number was 79405801 with an expiration date of 31-aug-2025.The qc was within the assigned ranges on the day of the event.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 27 patients' samples tested with the hba1c on a cobas c513 analyzer.The following are 3 representative examples: sample 1: initial result: 12.4 %.Repeat result: 6.0 %.Sample 2: initial result: 9.4 %.Repeat result: 5.5 %.Sample 3: initial result: 6.8 %.Repeat result: 5.7 %.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
A general reagent issue can be excluded because no further issues were reported, and a correct rerun was performed with the same reagent.The field service engineer found that the cell rinse nozzle was blocked by the small pieces of rubber that were used for the sample tube caps, leading to random droplets back into the routine cells.He opened up the blockage and confirmed that the test and the module were performing back within specifications.The root cause was due to a component failure (blockage).The troubleshooting actions performed by the engineer 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: 22131216
• Report Number: 1823260-2025-01700
• Device Sequence Number: 18231115
• 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): 06/25/2025

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: 05/09/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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