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	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with tina-quant hemoglobin a1c (hba1c) assay on a cobas 6000 c501 (ul) v module.Initial result: 5.9 % (tested on another c501).The physician questioned the initial result, and the sample was repeated at the same facility and at a sister laboratory.1st repeat result: 6.5 % (repeated on the c501).The 2nd repeat result obtained from the sister laboratory was deemed to be correct.
Additional Manufacturer Narrative
The c501 (ul) v module serial number was (b)(6).The qc was running high but still within range.The field service engineer found that the rinse volumes at the probe, rinse baths, and rinse mechanisms were low.He performed a health check, checked the mechanical adjustments of the probes, and adjusted rinse volumes and pump pressure.He then performed calibration, qc, and precision studies, and they were within specifications.The analyzer was then performing within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
The provided calibration recovery was successful with no alarms, but it showed that the customer recalibrated one application while not recalibrating the other.The alarm trace showed abnormal probe sucking, abnormal sample aspiration, and sample short alarms.These are indicators of possible poor sample quality.The service actions performed by the field service engineer resolved the issue.No further issues were reported after the service visit.The cause was traced to maintenance.

• 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: 22335964
• Report Number: 1823260-2025-01955
• Device Sequence Number: 8962903
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 03/31/2026
• Device Catalogue Number: 05336163190
• Device Lot Number: 80515001
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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