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

Catalog Number	08057923190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas c 503 analytical unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable tina-quant igm gen.2 results for qc material and patient samples from the cobas c 503 analytical unit.One example was provided of an initial result of 29 mg/dl and a repeat result of 14.4 mg/dl.The repeat result was obtained after recalibrating the assay.
Additional Manufacturer Narrative
The field service engineer checked the analyzer and performed precision testing that passed within the guidelines.The customer performed maintenance, daily startup, and qc without error and with results within the specified ranges.As qc recovery was within the acceptable range, there was no indication of a performance issue with the reagent or instrument.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21503249
• Report Number: 1823260-2025-00598
• Device Sequence Number: 18133290
• Product Code: DAO
• UDI-Device Identifier: 07613336121337
• UDI-Public: 07613336121337
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 82980401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/13/2025
• 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