MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGM IMMUNOGLOBULIN M; METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

Catalog Number 20737771322

Device Problem Low Test Results (2458)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for igm immunoglobulin m (igm) on a cobas integra 400 plus.The initial result was 2.41 g/l with a data flag.This result was reported outside of the laboratory where it was questioned by the doctor.The repeat result was 2.08 g/l with a data flag.The repeat result after dilution was 85.67 g/l with a data flag.The integra 400 plus serial number was (b)(4).

Manufacturer Narrative

Na.

Manufacturer Narrative

A new sample from the patient was tested with an initial igm result of 22.30 g/l with a data flag and a repeat result of 2.43 g/l.The result of 2.08 g/l provided in the initial report was accompanied by an "excess antigen" data flag.The investigation determined the initial sample had a very high concentration of igm in the sample.The antigen excess check is observed at concentrations higher than 58 g/l.For this sample, the result after dilution was 85.67 g/l.No additional information was provided for the 2nd sample obtained from the patient.The investigation determined the event was due to an issue with this particular patient.The investigation did not identify a product problem.

• Brand Name: IGM IMMUNOGLOBULIN M
• Type of Device: METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13618052
• MDR Text Key: 292816280
• Report Number: 1823260-2022-00530
• Device Sequence Number: 1
• Product Code: CFN
• UDI-Device Identifier: 04015630913725
• UDI-Public: 04015630913725
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K982382
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 20737771322
• Device Lot Number: 55410601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1