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	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application results for one patient sample tested on the cobas 6000 c501 module.Initial analysis yielded 8.7%.Repeat analysis yielded 5.9%.The doctor questioned the initial result, prompting the rerun.The repeat result was deemed correct.
Additional Manufacturer Narrative
The cobas 6000 c501 module serial number is (b)(6).

• 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: 50917882
• Report Number: 1823260-2026-03986
• Device Sequence Number: 5776559
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 09/28/2026

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: 951365
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• 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