MAUDE Adverse Event Report: Roche Diagnostics Tina-quant IgG Gen.2; Igg, Antigen

Catalog Number	03507432190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable tina-quant igg gen.2 results from the cobas 8000 cobas c 502 module.The samples were repeated on 29-july-2026.Sample 1 initial result was 13.9 g/l, and the repeat result was 7.87 g/l.Sample 2 initial result was 15.02 g/l, and the repeat result was 2 6.9 g/l.Sample 3 initial result was 17.9 g/l, and the repeat result was 10.76 g/l.Sample 4 initial result was 4.48 g/l, and the repeat result was 9.91 g/l.Sample 5 initial result was 7.79 g/l, and the repeat result was 11.05 g/l.Sample 6 initial result was 6.58 g/l, and the repeat result was 8.92 g/l.
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number was18h7-08 the field service engineer replaced the absorbance lamp and cuvettes.The investigation is ongoing.

• Brand Name: Tina-quant IgG Gen.2
• Common Device Name: Igg, Antigen
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50771793
• Report Number: 1823260-2026-03764
• Device Sequence Number: 13129457
• Product Code: DEW
• UDI-Device Identifier: 04015630919710
• UDI-Public: 04015630919710
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 03507432190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/15/2026
• 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: Unknown