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

Catalog Number	05220726190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c 702 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with igm-2 on a cobas 8000 c702 module.The sample initially resulted in an igm value of 39.66 g/l with a data flag.The sample was repeated three additional times using a decreased sample volume, resulting in igm values of 70.63 g/l with a data flag, 69.39 g/l, and 69.93 g/l.The sample was diluted 1:20 and repeated, resulting in an igm value of 36.93 g/l with a data flag.The sample was repeated using an increased sample volume, resulting in an igm value of 0.14 g/l.
Additional Manufacturer Narrative
High igm values are plausible and are due to the patient's condition (waldenstrom¿s macroglobulinaemia / lymphoplasmacytic lymphoma).The very low value of 0.14 g/l obtained using increased sample volume points to a high dose hook effect.For highly concentrated samples, dilutions using decreased sample volume or manual off-board dilutions are recommended.The 1:20 dilution was performed on board.Ordering additional dilutions directly on the instrument will cancel the automatic pre-dilution of the test and can potentially give false results due to missing pre-dilution.The investigation did not identify a product problem.

• Brand Name: IGM-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: 17828838
• Report Number: 1823260-2023-03122
• Device Sequence Number: 7182344
• 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): 12/08/2023

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: 716687
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 12/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY.
• Patient Age: 66 YR
• Patient Sex: Male