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

Catalog Number	20737771322
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem 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).
Additional Manufacturer Narrative
Na.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-00530
• Device Sequence Number: 12249907
• Product Code: CFN
• UDI-Device Identifier: 04015630913725
• UDI-Public: 04015630913725
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K982382
• 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): 03/21/2022

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: 08/31/2023
• Device Catalogue Number: 20737771322
• Device Lot Number: 55410601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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