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

Catalog Number	08057923190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for roche diagnostics tina-quant igm gen.2 (igm-2) on a cobas c 503 analytical unit.The initial result was 5.47 g/l.The repeat result was >63.0 g/l with an invalidating data flag.The sample was repeated with a manual dilution of 1:21 and the result was 59.85 g/l.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
The alarm trace data showed a high number of "abnormal aspiration" errors.Monoclonal gammopathy for the patient was confirmed.Product labeling states: "as with other turbidimetric or , this test may not provide accurate results in patients with monoclonal gammopathy, due to individual sample characteristics which can be assessed by electrophoresis." the investigation did not identify a product problem.

• Brand Name: ROCHE DIAGNOSTICS 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: 20020694
• Report Number: 1823260-2024-02425
• Device Sequence Number: 7363970
• Product Code: DAO
• UDI-Device Identifier: 07613336121337
• UDI-Public: 07613336121337
• Combination Product (Y/N): Y
• 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): 08/26/2024

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: 05/31/2025
• Device Catalogue Number: 08057923190
• Device Lot Number: 73833301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 08/26/2024
• 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