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

Catalog Number	07559674190
Medical Device Problem Codes	High Test Results (2457); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 513 analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant hemoglobin a1cdx gen.3 results from the cobas c 513 analyzer.The patient's initial result on 06-jun-2024 was 9.3%.On (b)(6) 2024, the result was 9.3%.On (b)(6) 2025, the result was 9.5%.On (b)(6) 2025, from a cobas c 503, the result was 9.25%.The doctor questioned the historical results as they did not match a fructosamine result, and the patient had a normal blood glucose result.The doctor ordered a high-performance liquid chromatography (hplc) test because the historical hba1c results did not match with the fructosamine and normal glucose results.On (b)(6) 2025, there was a (hplc) hba1c result of 5.43% and a result of 3.74% from an unknown source.
Additional Manufacturer Narrative
Medwatch fields b7 other relevant history and concomitant medical products updated.The patient sample is not available for investigation.The investigation analyzed the patient's hba1c results and determined that the result of 3.74% from the competitor analyzer was too low.The investigation determined the event was consistent with an unidentified hemoglobin variant in the patient's sample, which interfered with the competitor's assay method.The investigation did not identify a product problem.

• 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: 22176049
• Report Number: 1823260-2025-01784
• Device Sequence Number: 7818621
• Product Code: PDJ
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• 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): 10/27/2025

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: 07559674190
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 10/27/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METFORMIN
• Patient Age: 38 YR
• Patient Sex: Unknown