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

Catalog Number	07559674190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hba1c reagent expiration date was not provided.The cobas c 513 analyzer serial number was (b)(6).The preventive maintenance was last performed on 09-jun-2025.The field service engineer performed checks on the instrument and verified the gear pump pressure.He also verified the cuvettes and the rinse levels.He then flushed out and reverified the rinse levels of the solenoid valves as a precaution.Qc was performed, and the customer is monitoring the system.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable results for 3 patients' samples tested with tina-quant hemoglobin a1cdx gen.3 (hba1c) assay on a cobas c 513 analyzer, not matching the patients' clinical pictures.Patient 1: initial result: 12.1 %.Repeat result: 5.1 % (repeat from a different sample draw).Patient 2: initial result: >15 %.Repeat result: 5.1 % or 5.2 % (repeat from a different sample draw).Patient 3: initial result: >15.5 %.Repeat result: >15.5 % (repeat from the original sample draw).The physician questioned the initial results as they did not match the patients' history.The repeat results for patients 1 and 2 were deemed to be correct.Reportedly, the customer noted to call patient 3 back for a new sample withdraw.
Additional Manufacturer Narrative
Medwatch fields d1, d2a, d2b, d4, and g1 were updated.The qc was within the customer's established ranges before the event.The field service engineer checked the instrument and found no cause for the issue.He verified that the instrument was performing within specifications.No further issues were reported after the service visit.The investigation did not identify a product problem.The cause of the event was consistent with a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.
Additional Manufacturer Narrative
Medwatch fields d1, d2a, d2b, d4, and g1 were updated.The customer submitted a medwatch report to the fda with a medwatch number of mw5177380.The calibration was last performed on (b)(6) 2025, and it was acceptable.The alarm trace observed no relevant alarms.The investigation is ongoing.

• 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 46250-0457
• MDR Report Key: 23004558
• Report Number: 1823260-2025-02792
• Device Sequence Number: 21237464
• Product Code: PDJ
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160571
• 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,Followup
• Report Date (Section B): 12/18/2025

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 Catalogue Number: 07559674190
• Device Lot Number: 801605
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 12/09/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/13/2025; 12/18/2025
• 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