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); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The requested information for the investigation was not provided.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The cobas integra 400 plus analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant hba1c results from 1 patient sample tested on cobas integra 400 plus analyzer when compared to a cobas c501 module.Initial result: 7.6 %.The customer questioned the initial result and repeated the sample.No questionable result was reported outside the laboratory.Repeat result: 5.4 % (tested on c501).The repeat result was considered correct and reported to the physician and the patient.

• 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: 20777577
• Report Number: 1823260-2024-03428
• Device Sequence Number: 15476029
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/13/2024

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: 09/30/2025
• Device Catalogue Number: 05336163190
• Device Lot Number: 78282101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/01/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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 Sex: Unknown