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

Catalog Number	05220726190
Medical Device Problem Codes	Incorrect Measurement (1383); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c702 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with tina-quant igm gen.2 on a cobas 8000 c702 module.The patient sample was analyzed via electrophoresis, resulting in an igm value of 50 g/l on (b)(6) 2024.When the patient sample was tested on the c 702 analyzer, it resulted in values of 4.249 g/l on (b)(6) 2024, 4.787 g/l on (b)(6) 2024, and 5.152 g/l on (b)(6) 2024.The patient sample resulted in an additional value of 4.23 g/l when tested on the c702 analyzer.The sample was automatically diluted on the analyzer 1:10 and repeated, resulting in a raw value of 0.529 g/l on (b)(6) 2024.This calculates to a final value of 5.29 g/l.
Additional Manufacturer Narrative
The customer stated that the patient has gammopathy.The investigation determined the issue is consistent with the gammopathy of the patient.Additionally, the customer used a 1:10 instrument dilution.The tina-quant igm gen.2 assay is automatically pre-diluted by the analyzer at a 1:21 standard pre-dilution.By ordering the 1:10 instrument dilution, the analyzer will cancel the automatic pre-dilution of the test.Qc data from june 2024 showed imprecision, with high and low results that were within 3 standard deviations of the mean.The calibration data showed some degree of calibration failure.The investigation did not identify a product issue.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19795236
• Report Number: 1823260-2024-02112
• Device Sequence Number: 17941843
• Product Code: DAO
• UDI-Device Identifier: 04015630925742
• UDI-Public: 04015630925742
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 08/20/2024

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 Catalogue Number: 05220726190
• Device Lot Number: 791236
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/21/2024
• 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 Age: 43 YR
• Patient Sex: Unknown