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

Catalog Number	08056668190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated they received questionable hba1c results for a second patient sample tested on (b)(6) 2024.This sample initially resulted in an hba1c value of 14.5 %.A physician questioned the result.When repeated on (b)(6) 2024, the result was 5.48 %.Upon review of the alarm trace, many abnormal aspiration errors were observed.These alarms may indicate issues with sample quality.The investigation could not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The serial number of the c 303 analyzer is (b)(6).Upon review of the alarm trace, multiple abnormal aspiration alarms were observed.The investigation is ongoing.
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 pure c 303 analytical unit.The sample initially resulted in an hba1c value of 10.9 %.The value was questioned by a physician as the result did not correlate with the patient's clinical state.The sample was repeated on (b)(6) 2024, resulting in an hba1c value of 5.09 %.
Additional Manufacturer Narrative
For the second patient sample, the repeat hba1c result of 5.48 % was deemed correct as it matched the patient's history.

• 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: 19733001
• Report Number: 1823260-2024-02018
• Device Sequence Number: 12779139
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): Y
• Initial Reporter Country: TC
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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: 12/31/2024
• Device Catalogue Number: 08056668190
• Device Lot Number: 744200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 08/05/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/01/2024; 08/06/2024
• 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