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

Catalog Number	08056668190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for samples from one patient tested with tina-quant hemoglobin a1cdx gen.3 on a cobas c 503 analytical unit.The results allegedly do not match the patient's clinical condition.The physician expected lower patient results based on results obtained with a continuous blood monitor (cbm) device.The patient's continuous blood monitor shows a glucose management indicator result below 7 %.The patient's average cbm glucose is 145 mg/dl.The cbm is replaced every 15 days and it correctly placed.On (b)(6) 2026, a first sample collected from the patient resulted in an hba1c value of 7.7%.On (b)(6) 2026, a second sample collected from the patient was tested twice, each time resulting in an hba1c value of 8.2 %.On (b)(6) 2026, a third sample collected from the patient resulted in an hba1c value of 7.9 %.
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls were acceptable.The instrument and the reagent are performing as specified based on the provided data.Hba1c values and cgm testing results cannot be directly compared.

• 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: 25159408
• Report Number: 1823260-2026-01877
• Device Sequence Number: 9316232
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K193053
• 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): 06/08/2026

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: 08/31/2026
• Device Catalogue Number: 08056668190
• Device Lot Number: 87246501
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/08/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INSULIN
• Patient Age: 69 YR
• Patient Sex: Male