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

Catalog Number	05336163190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c311 analyzer is (b)(6).The water tank was cleaned, the cells were replaced, the water path was cleaned, and maintenance was performed on the analyzer.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for 5 patient samples tested with tina-quant hbalc gen.3 on a cobas 4000 c311 stand alone system.The results were measured using two different lots of hba1c reagent in comparison to results measured with an unknown competitor method.The first sample resulted in an hba1c value of 4.27 % when tested with reagent lot 751302 and it resulted in a value of 4.8 % when tested with reagent lot 736996.When tested with the competitor method, it resulted in a value of 5.4 %.The second sample resulted in an hba1c value of 4.49 % when tested with reagent lot 751302 and it resulted in a value of 5.08 % when tested with reagent lot 736996.When tested with the competitor method, it resulted in a value of 5.3 %.The third sample resulted in an hba1c value of 6.42 % when tested with reagent lot 751302 and it resulted in a value of 6.74 % when tested with reagent lot 736996.When tested with the competitor method, it resulted in a value of 8.5 %.The fourth sample resulted in an hba1c value of 5.07 % when tested with reagent lot 751302 and it resulted in a value of 5.58 % when tested with reagent lot 736996.When tested with the competitor method, it resulted in a value of 5.6 %.The fifth sample resulted in an hba1c value of 5.04 % when tested with reagent lot 751302 and it resulted in a value of 5.62 % when tested with reagent lot 736996.When tested with the competitor method, it resulted in a value of 5.6 %.The competitor results were reported to the patient.The competitor results and results measured with lot 736996 were more compatible with the history of the patients.
Additional Manufacturer Narrative
The field service engineer adjusted the reagent probe and performed preventive maintenance on the analyzer.No further issues occurred after these actions.There was no indication of a general reagent problem.The investigation determined the service actions resolved the issue.

• 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: 18924874
• Report Number: 1823260-2024-00796
• Device Sequence Number: 11907097
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• 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): 04/19/2024

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: 05336163190
• Device Lot Number: 751302, 736996
• 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: 03/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/19/2024
• 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