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

Catalog Number	07559674190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The repeat results were ran on a cobas c 513 analyzer with the serial number: (b)(6).The customer has not provided the serial number for the instrument that the initial results were generated.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 after having an issue of high bias on a cap survey.Patient (b)(6) initial result on (b)(6) 2025 was 15.3%, with a repeat result of 14.2%.Patient (b)(6) initial result on (b)(6) 2025 was 15.5%, with a repeat result of 13.7%.Patient (b)(6) initial result on (b)(6) 2025 was 7.7%, with a repeat result of 7.1%.Patient (b)(6) initial result on (b)(6) 2025 was 6.8%, with a repeat result of 6.2%.Patient (b)(6) initial result on (b)(6) 2025 was 6.2%, with a repeat result of 5.6%.Patient (b)(6) initial result on (b)(6) 2025 was 7.6%, with a repeat result of 6.9%.Patient (b)(6) initial result on (b)(6) 2025 was 7.6%, with a repeat result of 7.0%.Patient (b)(6) initial result on (b)(6) 2025 was 7.6%, with a repeat result of 7.0%.Patient (b)(6) initial result on (b)(6) 2025 was 7.6%, with a repeat result of 7.0%.Patient (b)(6) initial result on (b)(6) 2025 was 7.3%, with a repeat result of 6.7%.Patient (b)(6) initial result on (b)(6) 2025 was 8.2%, with a repeat result of 7.5%.Patient (b)(6) initial result on (b)(6) 2025 was 7.5%, with a repeat result of 6.9%.Patient (b)(6) initial result on (b)(6) 2025 was 7.1%, with a repeat result of 6.5%.The customer is unsure which results are correct.The initial results were repeated because they were questioned in a correlation study.
Additional Manufacturer Narrative
Calibration, qc, and alarm trace reports were not provided.No material has been received for investigation.The investigation was unable to determine a direct root cause.

• 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: 22104457
• Report Number: 1823260-2025-01640
• Device Sequence Number: 20868148
• Product Code: PDJ
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/13/2025

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: 05/29/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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