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

Catalog Number	08445699190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c503 is (b)(6).The serial number of the c303 analyzer is (b)(6).A new lot calibration was performed on one of the instruments and the control recovery improved.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they have been having ongoing issues with patient samples tested with tina-quant hemoglobin a1cdx gen.3 on a cobas pro c 503 analytical unit and a cobas pure c 303 analytical unit.The c503 instrument generally measured hba1c values that were around 1 % higher than other hospitals, particularly for higher values.The customer tested one patient sample for hba1c on the c503 and c303 instruments.The c503 hba1c result was 7.74 % and the c303 result was 7.08 %.The customer stated that the actual value based on clinical symptoms should be about 7.3 %.
Additional Manufacturer Narrative
The investigation could not identify a product problem.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: 18336239
• Report Number: 1823260-2023-04044
• Device Sequence Number: 6739803
• Product Code: LCP
• UDI-Device Identifier: 07613336157824
• UDI-Public: 07613336157824
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 01/02/2024

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 Catalogue Number: 08445699190
• Device Lot Number: ASKU
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 12/25/2023
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/02/2024
• 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 Sex: Unknown