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

Catalog Number	08056668190
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hba1c reagent lot number was 821679.The reagent expiration date was requested, but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with tina-quant hemoglobin a1cdx gen.3 on a cobas c 503 analytical unit.The sample initially resulted in an hba1c value of 6.4 %.A doctor questioned the result, so the sample was repeated.The repeat result was 5.7 % and this value was deemed correct.
Additional Manufacturer Narrative
The customer stated that quality controls were within range.A roche field application specialist visited the site and determined that the customer's control ranges were too large and that the ranges should be tightened in order to detect shifts.No further issues were reported by the customer.The investigation could not identify a product problem.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• 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: 22412976
• Report Number: 1823260-2025-02071
• Device Sequence Number: 21251029
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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 Catalogue Number: 08056668190
• Device Lot Number: 821679
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG