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

Model Number	D381996
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure c303 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable results for 3 patients' samples tested with the hba1c on a cobas pure c303 analytical unit.Sample 1 (patient 1): initial result: 7.18 %.Repeat result: 6.1 % (tested using immunofluorescence methodology).Sample 2 (patient 2): initial result: 6.3 %.Repeat result: 4.8 % (tested using immunofluorescence methodology).Sample 3 (patient 3): initial result: 11.4 %.1st and 2nd repeat results were both 9.0 % (tested using immunofluorescence methodology).
Additional Manufacturer Narrative
The results were used only as a comparison study and not for diagnostic purposes.The calibration was acceptable, but the qc was out of range.The field service engineer found that the base solution (basic wash) was not dispensing correctly, and the solenoid valve was stuck.He cleaned the shaft plunger of the valve winding.Qc was performed, and samples were tested with acceptable results.Based on the outcome of the service visit, the above instrument-related issues were found and corrected, but these issues were not the root cause of the event.This could be clearly demonstrated by the comparative measurements at the customer side.The investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21677147
• Report Number: 1823260-2025-00848
• Device Sequence Number: 12819636
• Product Code: PDJ
• UDI-Device Identifier: 07613336157824
• UDI-Public: 07613336157824
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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 Expiration Date: 10/31/2025
• Device Model Number: D381996
• Device Catalogue Number: 08445699190
• Device Lot Number: 80176701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/05/2025
• 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