MAUDE Adverse Event Report: Roche Diagnostics Tina-quant Hemoglobin A1c Gen.3 - Hemolysate and Whole Blood Application; Assay, Glycosylated Hemoglobin

Catalog Number	05336163190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results with the tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application for a patient sample tested on the cobas 4000 c311 stand alone system.The initial result was 4.89%.The repeat result was 5.95%.The repeat result was deemed correct as as it was more compatible with the patients history.

• Brand Name: Tina-quant Hemoglobin A1c Gen.3 - Hemolysate and Whole Blood Application
• Common Device Name: Assay, Glycosylated Hemoglobin
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50882036
• Report Number: 1823260-2026-03930
• Device Sequence Number: 15909266
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K102914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 05336163190
• Device Lot Number: 908583
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/06/2026
• Initial Report FDA Received Date: 09/24/2026
• 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