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

Catalog Number	08057915190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Roche diagnostics received a customer complaint regarding alleged discrepant tina-quant igg gen.2 assay results for one cerebrospinal fluid (csf) patient sample tested on the cobas 8000 cobas c 502 module.\ \ the initial result was 7.98 mg/l.\ the first repeat result was 404 mg/l with an invalidating data flag.\ the second repeat result at 1:10 manual dilution in decreased mode was 732 mg/l with a data flag; the final calculated result was 7320 mg/l.\ the third repeat result at 1:10 manual dilution was 7130 mg/l.
Additional Manufacturer Narrative
The cobas 8000 cobas c 502 module serial number is (b)(6).

• Brand Name: Tina-quant IgG Gen.2
• Common Device Name: Igg, antigen, antiserum, control
• 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: 50800777
• Report Number: 1823260-2026-03794
• Device Sequence Number: 10610943
• Product Code: DEW
• UDI-Device Identifier: 07613336121320
• UDI-Public: 07613336121320
• 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): 09/17/2026

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: 08057915190
• Device Lot Number: 944314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• 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