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

Catalog Number	05336163190
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	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the integra 400 plus analyzer is (b)(6).The field service engineer observed that the washing tower had an unusual overflow of droplets during the washing process.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with tina-quant hbalc gen.3 on a cobas integra 400 plus.The first sample initially resulted in an hba1c value of 6.52 % and it repeated as 7.33 %.The second sample initially resulted in an hba1c value of 14.02 % with a data flag and it repeated as 12.48 %.The third sample initially resulted in an hba1c value of 6.93 % on (b)(6) 2024 and it repeated as 7.5 %.
Additional Manufacturer Narrative
The field service engineer replaced the lamp and cleaned all light and cuvette paths.The work stations and mixing mechanisms were checked.Calibrations were performed and were acceptable.Following calibration, precision issues were improved.Controls were run and the results were acceptable.The service engineer indicated the lamp was unstable.The investigation could not identify a product problem.The issue is consistent with insufficient customer maintenance.

• Brand Name: TINA-QUANT HBALC GEN. 3
• Common Device Name: ASSAY, GLYCOSYLATED HEMOGLOBIN
• 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: 18944815
• Report Number: 1823260-2024-00832
• Device Sequence Number: 8381815
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): Y
• Initial Reporter Country: SA
• PMA/510(K) Number: K102914
• 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): 04/03/2024

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: 06/30/2025
• Device Catalogue Number: 05336163190
• Device Lot Number: 73376801
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/03/2024
• 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