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	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration results were within the specified ranges.The qc results were within the specified ranges.The alarm trace had abnormal aspiration and abnormal liquid level alarms.The customer did not report any other issues after the service.The investigation determined that the service actions resolved the issue.The event's cause could not be determined.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The serial number of the customer's cobas c 503 analytical unit (b)(6).The field service engineer (fse) inspected and cleaned the analyzer; checked and aligned the sample and reagent probes; and checked and adjusted the rinse water.He verified the analyzer's performance with a successful precision checks and the customer performed successful qcs.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable tina-quant hemoglobin a1cdx gen.3 assay result from one patient sample tested on the cobas c 503 analytical unit the initial result was 6.0%.The repeat result was 4.9%.The repeat result was deemed correct.The physician deemed the initial result too high for the patient's clinical picture, prompting the patient's sample to be rerun.

• 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: 21984475
• Report Number: 1823260-2025-01415
• Device Sequence Number: 4478887
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/09/2025

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: 08056668190
• Device Lot Number: 794063
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/09/2025
• 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