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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hba1c reagent lot 83940601 has an expiration date of 31-jul-2026.Hba1c reagent lot 88803001 has an expiration date of 31-mar-2027.Calibration data showed no alarms, but controls showed imprecision and significant increase after the calibration performed on 17-apr-2026.The investigation could not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested with tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application on a cobas integra 400 plus.The customer states that most patient results for hba1c have been above the reference range in routine testing.These are samples from young patients, without comorbidities, and with no history of altered glycemia.The customer has tried different reagent cassettes and have tried recalibrating, but the issue persists.The customer provided an example of one patient sample with discrepant hba1c results.The patient sample was tested using reagent lot 83940601, resulting in an hba1c value of 6.02 %.The patient sample was tested using reagent lot 88803001, resulting in an hba1c value of 5.51 %.

• 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 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: 25259880
• Report Number: 1823260-2026-02046
• Device Sequence Number: 20207576
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K102914
• 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
• Report Date (Section B): 05/22/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 05336163190
• Device Lot Number: 83940601, 88803001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/22/2026
• 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