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

Catalog Number 05336163190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the integra 400 plus analyzer is (b)(6).The field service engineer observed that the washing tower had an unusual overflow of droplets during the washing process.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with tina-quant hbalc gen.3 on a cobas integra 400 plus.The first sample initially resulted in an hba1c value of 6.52 % and it repeated as 7.33 %.The second sample initially resulted in an hba1c value of 14.02 % with a data flag and it repeated as 12.48 %.The third sample initially resulted in an hba1c value of 6.93 % on (b)(6) 2024 and it repeated as 7.5 %.

Manufacturer Narrative

The field service engineer replaced the lamp and cleaned all light and cuvette paths.The work stations and mixing mechanisms were checked.Calibrations were performed and were acceptable.Following calibration, precision issues were improved.Controls were run and the results were acceptable.The service engineer indicated the lamp was unstable.The investigation could not identify a product problem.The issue is consistent with insufficient customer maintenance.

• Brand Name: TINA-QUANT HBALC GEN. 3
• Type of Device: ASSAY, GLYCOSYLATED HEMOGLOBIN
• 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: 18944815
• MDR Text Key: 338316747
• Report Number: 1823260-2024-00832
• Device Sequence Number: 1
• Product Code: LCP
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (y/n): Y
• Reporter Country Code: SA
• PMA/PMN Number: K102914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05336163190
• Device Lot Number: 73376801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1