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	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the complained c513 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for seven patient samples tested with tina-quant hemoglobin a1cdx gen.3 on a cobas c513 analyzer commercial system.The customer noticed a positive bias in patient hba1c results and repeated these using an hplc method and a second c513 analyzer.The first sample initially resulted in an hba1c value of 5.50 %.When repeated with the hplc method, the result was 4.80 %.When repeated on the second c513 analyzer, the result was 5.20 %.The second sample initially resulted in an hba1c value of 5.70 %.When repeated with the hplc method, the result was 5.00 %.When repeated on the second c513 analyzer, the result was 5.50 %.The third sample initially resulted in an hba1c value of 5.30 %.When repeated with the hplc method, the result was 4.70 %.When repeated on the second c513 analyzer, the result was 5.00 %.The fourth sample initially resulted in an hba1c value of 6.80 %.When repeated with the hplc method, the result was 6.20 %.When repeated on the second c513 analyzer, the result was 6.60 %.The fifth sample initially resulted in an hba1c value of 5.60 %.When repeated with the hplc method, the result was 5.00 %.When repeated on the second c513 analyzer, the result was 5.40 %.The sixth sample initially resulted in an hba1c value of 5.70 %.When repeated with the hplc method, the result was 4.90 %.When repeated on the second c513 analyzer, the result was 5.40 %.The seventh sample initially resulted in an hba1c value of 5.70 %.When repeated with the hplc method, the result was 5.10 %.When repeated on the second c513 analyzer, the result was 5.50 %.
Additional Manufacturer Narrative
The central processing unit (cpu) of the analyzer was replaced with the cpu of a second analyzer.All data from the complained analyzer was deleted.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 18639931
• Report Number: 1823260-2024-00318
• Device Sequence Number: 20826595
• Product Code: LCP
• UDI-Device Identifier: 04015630942787
• UDI-Public: 04015630942787
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 02/12/2024

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: 08/31/2024
• Device Catalogue Number: 07559674190
• Device Lot Number: 71888501
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 02/10/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/12/2024
• 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