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

Catalog Number	08445699190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).The cobas pure analyzer serial number was not provided.
Event or Problem Description
The initial reporter complained of discrepant results for 2 pediatric patient samples tested for tina-quant hemoglobin a1cdx gen.3 on a cobas c 503 analytical unit and a cobas pure instrument compared to an unspecified electrophoresis method.On (b)(6) 2024 "patient 2" result from the cobas pure instrument was 6.2% (44.2 mmol/mol).On (b)(6) 2024 the repeat from the c503 analyzer was 5.97% (41.7 mmol/mol).The repeat result from the electrophoresis method was 5.6% (37 mmol/mol).On (b)(6) 2024 "patient 1" result from the c503 analyzer was 5.86% (40.5 mmol/mol).The repeat result was 5.72% (39 mmol/mol).The repeat result from the electrophoresis method was 5.4% (35 mmol/mol).Based on the reference ranges used by the customer, the results from the cobas c503 analyzer and cobas pure instrument are considered high risk for diabetes and the results from the electrophoresis method are deemed normal.
Additional Manufacturer Narrative
The probes and rinse levels for cells and probes were reportedly correctly adjusted.The cells have not been replaced since the instrument was installed; the cells should be replaced monthly as part of routine maintenance.Based on the information provided, the cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19260544
• Report Number: 1823260-2024-01375
• Device Sequence Number: 2686029
• Product Code: LCP
• UDI-Device Identifier: 07613336157824
• UDI-Public: 07613336157824
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K072714
• 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): 06/13/2024

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: 12/31/2024
• Device Catalogue Number: 08445699190
• Device Lot Number: 74419901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/13/2024
• 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: 7 YR
• Patient Sex: Unknown