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	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hba1c reagent expiration date was not provided.The cobas pure c303 analytical unit serial number was (b)(6).Calibration and qc were within ranges prior to the event.The alarm trace showed abnormal aspiration alarms for the sample probe.The cells are replaced monthly.The sample probe was checked and no issues were found.All rinse levels for the cells and the probes were adjusted correctly.The reagent probes were adjusted correctly.The cells get completely dry after cell wash.There was no visible residual water in the cells.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 5 patients' samples tested with hba1c on a cobas pure c303 analytical unit.Sample 1 (patient 1) was tested on 26-sep-2024: initial result: 10.5 % (accompanied by a data flag).Repeat result: 6.11 %.This sample was a whole blood sample.Sample 2, sample 3, sample 4, and sample 5 were tested on 14-oct-2024: sample 2 (patient 2): initial result: 8.00 %.Repeat result: 5.22 %.Sample 3 (patient 3): initial result: 6.88 %.Repeat result: 4.70 %.Sample 4 (patient 4): initial result: 7.49 %.Repeat result: 5.14 %.Sample 5 (patient 5): initial result: 7.87 %.Repeat result: 4.96 %.
Additional Manufacturer Narrative
The requested data for investigation was not provided despite several reminders.The investigation did 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: 20689392
• Report Number: 1823260-2024-03323
• Device Sequence Number: 9058794
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): N
• Initial Reporter Country: RW
• 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): 12/18/2024

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: 08056668190
• Device Lot Number: 794037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/18/2024
• 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