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

Catalog Number	08056668190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was observed that the sample probe was covered in gel.The mixer adjustment was checked and it was ok.Probes were changed and adjusted.Precision studies were performed but were not acceptable.The rinse station was cleaned and it was determined that it needed adjusting.The wash station was adjusted and after this, recovery was acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with tina-quant hemoglobin a1cdx gen.3 on a cobas pro c 503 analytical unit.The first sample initially resulted in an hba1c result of 8.4 %.A second sample collected from the patient resulted in an hba1c value of 5.5 %.The first sample was then repeated on (b)(6) 2023, resulting in a value of 5.5 %.The second patient sample initially resulted in an hba1c value of 9.53 % and it repeated as 7.34 %.The third patient sample resulted in the following hba1c values on (b)(6) 2023: 6.39 %, 9.36 %, 7.34 %, 8.19 %, 7.19 %, 6.95 %, 8.64 %, 12.5 %, 9.94 %, 12.2 %, and 7.05 %.
Additional Manufacturer Narrative
The alarm trace showed frequent abnormal aspiration alarms.This could indicate a contamination of the probe.A photo of the probe showed contamination.The investigation determined the action of adjusting the wash station resolved the issue.

• 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: 17808529
• Report Number: 1823260-2023-03085
• Device Sequence Number: 7174685
• Product Code: LCP
• UDI-Device Identifier: 07613336120927
• UDI-Public: 07613336120927
• Combination Product (Y/N): Y
• Initial Reporter Country: PK
• 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): 10/26/2023

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: 05/31/2024
• Device Catalogue Number: 08056668190
• Device Lot Number: 698253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/26/2023
• 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