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

Catalog Number	05220726190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with tina-quant igm gen.2 assay on a cobas 8000 c702 module.On (b)(6) 2026: initial result: 2894.9 mg/dl (accompanied by an invalidating data flag).1st repeat result: 2816.1 mg/dl (tested with dilution).On (b)(6) 2026: the physician requested that a protein electrophoresis be performed, and the electrophoresis image did not correspond to the igm value, which is around 2000 mg/dl.The original sample was then repeated, and the 2nd repeat result was approximately 300 mg/dl.No exact result was provided.On (b)(6) 2026: 3rd repeat result: 278 mg/dl.The 2nd repeat result of approximately 300 mg/dl was deemed to be correct.
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).Calibration and qc were within the acceptable ranges.The investigation is ongoing.

• Brand Name: TINA-QUANT IGM GEN.2
• Common Device Name: IGM (MU CHAIN SPECIFIC)
• 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: 24420356
• Report Number: 1823260-2026-00635
• Device Sequence Number: 12247174
• Product Code: DAO
• UDI-Device Identifier: 04015630925742
• UDI-Public: 04015630925742
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/19/2026

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: 05220726190
• Device Lot Number: 864057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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: Male