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

Catalog Number 05220726190

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the c 702 analyzer is (b)(6).The investigation is ongoing.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 324406267
• Report Number: 1823260-2023-03122
• Device Sequence Number: 1
• Product Code: DAO
• UDI-Device Identifier: 04015630925742
• UDI-Public: 04015630925742
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K040431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05220726190
• Device Lot Number: 716687
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY.
• Patient Age: 66 YR
• Patient Sex: Male