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

Catalog Number	07649142001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A reagent issue was excluded as qc and calibration data were inconspicuous.The field service engineer (fse) performed multiple actions, including adjusting the gear pump pressure, correcting the reaction cells, decontaminating the syringe path, adjusting all probes, and cleaning tubes.The instrument was monitored, and no further issues occurred.The investigation determined that the issue was hardware-related and the service actions resolved the issue.As multiple countermeasures were performed at the same time, the exact root cause could not be isolated.Medwatch fields d1, d2, d4, g1, and g4 have been updated.
Event or Problem Description
There was an allegation of questionable tina-quant hemoglobin a1cdx gen.3 assay results for seven patient samples tested on a cobas c513 analyzer.Sample 1: the initial result was 15.19% while the repeat result was 6.04%.Sample 2: the initial result was 10.06% while the repeat result was 4.91%.Sample 3: the initial result was 9.54% while the repeat result was 5.78%.Sample 4: the initial result was 10.75% while the repeat result was 5.40%.Sample 5: the initial result was 7.91% while the repeat results were 10.10% and 7.99%.Sample 6: the initial result was 10.40% while the repeat result was 4.74%.Sample 7: the initial result was 7.87% while the repeat result was 6.01%.The test was repeated due to the initial result not matching previous results.
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.

• 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: 22478605
• Report Number: 1823260-2025-02115
• Device Sequence Number: 12886385
• Product Code: JJE
• UDI-Device Identifier: 04015630946327
• UDI-Public: 04015630946327
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/18/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 07649142001
• Device Lot Number: 80175501
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/18/2025
• 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