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

Catalog Number	05336163190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas integra 400 plus analyzer serial number is (b)(4).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with tina-quant hbalc gen.3 on a cobas integra 400 plus.The patient sample resulted in an hba1c value of 6.27 %.The patient's treating doctor questioned the result because if did not match the patient's clinical presentation.The patient was not diabetic.A second sample was collected from the patient at another laboratory and the result for this sample was 5.2 %.
Additional Manufacturer Narrative
Investigations determined the customer is not performing calibration every 29 days according to instructions for use.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 20709431
• Report Number: 1823260-2024-03349
• Device Sequence Number: 8211998
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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: 10/31/2025
• Device Catalogue Number: 05336163190
• Device Lot Number: 79012301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 11/18/2024
• 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