MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2; IGM (MU CHAIN SPECIFIC) TEST

Catalog Number	08057923190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's sample tubes tested with tina-quant igm gen.2 (igm-2) assay on a cobas c503 analytical unit.Two sample tubes (sample tube 1 and sample tube 2) were drawn from the patient and tested.Sample tube 1: initial result: 34.3 g/l (accompanied by a data flag).Repeat result: 30.80 g/l (automatically rerun with dilution).Sample tube 2 was tested in a different laboratory: result obtained from a different cobas c503: 18 g/l.Result obtained from electrophoresis: 18.0 g/l.The physician questioned the results as they were inconsistent, prompting the repeat of the sample tubes on (b)(6) 2025: sample tube 2 was tested on a cobas c303 at a different laboratory, and the result was 14.6 g/l.Sample tube 1 was repeated on the original c503, resulting in an igm-2 value of 18.0 g/l and accompanied by a data flag.Sample tube 1 was rerun after dilution, resulting in an igm-2 value of 15.4 g/l.The result of 18 g/l obtained from a different cobas c503 at a different laboratory was deemed to be correct.
Additional Manufacturer Narrative
Section b7 was updated.The sample is no longer available for investigation.Qc was acceptable.The field service engineer found that rinse levels were low.The customer confirmed the issue was due to cryoglobulin in the sample.The presence of cryoglobulin can lead to nonspecific turbometric effects and, therefore, generate incorrect high results.The product labeling states: "as with other turbidimetric or nephelometric procedures, this test may not provide accurate results in patients with monoclonal gammopathy, due to individual sample characteristics which can be assessed by electrophoresis." based on the available data and observed failure mode, there is no evidence for a general instrument and reagent issue.The investigation did not identify a product problem.The root cause was due to a sample-related issue (the presence of cryoglobulin in the patient's sample, which interfered with the igm testing on the cobas analyzers).

• Brand Name: TINA-QUANT IGM GEN.2
• Common Device Name: IGM (MU CHAIN SPECIFIC) TEST
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22344595
• Report Number: 1823260-2025-01966
• Device Sequence Number: 12889886
• Product Code: DAO
• UDI-Device Identifier: 07613336121337
• UDI-Public: 07613336121337
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040431
• 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): 08/22/2025

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: 08/31/2026
• Device Catalogue Number: 08057923190
• Device Lot Number: 829804
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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