MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT HEMOGLOBIN A1C GEN.3 - HEMOLYSATE AND WHOLE BLOOD APPLICATION; ASSAY, GLYCOSYLATED HEMOGLOBIN

Model Number	A1C
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
1.There was an allegation questionable tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application results for two patients from the cobas 8000 cobas c 502 module.2.Patient age range: 32-56 years.3.Patient weight range: asku.4.Patient sex breakdown: 2 males.5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
Summary of investigation results: the investigation is ongoing.Summary of follow-up/corrective actions taken: the investigation is ongoing.Device returned to manufacturer? no.Device labeled "for single use?"? no.Device reprocessed and reused? no.
Additional Manufacturer Narrative
1.Summary of investigation results: the investigation did not identify a product problem.The cause of the event could not be determined.2.Summary of follow-up/corrective actions taken: the field service engineer performed preventive maintenance.The customer performed new comparisons with patient samples and qc, and the results were within specifications.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21925109
• Report Number: 1823260-2025-01310
• Device Sequence Number: 8728419
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• PMA/510(K) Number: K102914
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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?: No
• Device Expiration Date: 10/31/2025
• Device Model Number: A1C
• Device Catalogue Number: 05336163190
• Device Lot Number: 79012301
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown