MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT HEMOGLOBIN A1CDX GEN.3; GLYCOSYLATED HEMOGLOBIN ASSAY

Catalog Number	07559674190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 23 patients' samples tested for hba1c on a cobas c513 analyzer.The patients were tested on different dates between (b)(6) 2024 and (b)(6) 2025.The following are examples of discrepant results for 3 patients' samples.Patient 1: initial result: 7.5 %.Repeat result: 6.9 %.Patient 2 was tested on (b)(6) 2025: initial result: 13.8 %.Repeat result: 12.7 %.Patient 3 was tested on (b)(6) 2025: initial result: 7.1 %.Repeat result: 6.5 %.The samples were repeated on different c513 analyzers.
Additional Manufacturer Narrative
The hba1c reagent expiration date was not provided.The cobas c513 analyzer serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer believed that the results obtained at their facility were the most accurate.The data was requested for further investigation, but was not provided.The instrument performance was verified.No further issues were reported after the service visit.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: TINA-QUANT HEMOGLOBIN A1CDX GEN.3
• Common Device Name: GLYCOSYLATED HEMOGLOBIN ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22112944
• Report Number: 1823260-2025-01659
• Device Sequence Number: 4250919
• Product Code: PDJ
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/16/2025

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: 07559674190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/16/2025
• 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 Age: 70 YR
• Patient Sex: Female