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

Catalog Number	07559674190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with tina-quant hemoglobin a1cdx gen.3 on a cobas c513 analyzer commercial system.The sample initially resulted in an hba1c value of 9.3 %.The physician questioned the result as it did not match the clinical picture of the patient.The sample was repeated, resulting in a value of 6.2 %.The repeat value was deemed correct and matched the patient's history.
Additional Manufacturer Narrative
The serial number of the c513 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The last calibration performed on 18-feb-2024 was acceptable.The customer stated that controls were acceptable prior to the event.Upon review of the alarm trace, no relevant alarms were observed on the day of the event.The field service engineer could not determine a cause.The customer stated the issue was related to the patient sample.Samples run before and after the questionable sample showed results that could be duplicated.The system fluidics, mechanical adjustments, and washes were checked.All calibration and controls were acceptable.The customer indicated that the questionable sample may not have been mixed prior to being run.The investigation could not identify a product problem.The issue is consistent with insufficient pre-analytic sample handling.

• 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: 18839849
• Report Number: 1823260-2024-00658
• Device Sequence Number: 7457374
• Product Code: LCP
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 07559674190
• Device Lot Number: 715055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/01/2024
• 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 Age: 71 YR
• Patient Sex: Female