MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGM; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number	CMV IGM ELECSYS E2G
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant negative results for 1 patient sample tested for elecsys cmv igg (cmv igg) and elecsys cmv igm (cmv igm) on a cobas e 801 module.This medwatch will cover cmv igm.Refer to medwatch with a1 patient identifier (b)(6).For information on the cmv igg results.The cmv igm result from the e801 module was 0.635 coi (negative).The cmv igg result from the e801 module was 0.408 u/ml (negative).The sample was repeated by the chorus method and the results were positive.The specific results were not provided.No questionable results were reported outside of the laboratory.The e801 module serial number was (b)(6).
Additional Manufacturer Narrative
The sample was requested for investigation.
Additional Manufacturer Narrative
For pcr testing, real-time taqman probes and thermocycler bio-rad cfx 96 were used.Further investigations performed with the patient samples determined that an acute primary infection in the early phase is indicated for the patient.Detection of a seroconversion to igg was delayed with the elecsys cmv igg assay compared to other methods.Epitopes required for the detection of this rare sample are not sufficiently represented in the elecsys cmv igg assay.Based on the sensitivity claims for the elecsys cmv igm assay, single false negatives can occur.The reagent performs within specifications.
Additional Manufacturer Narrative
Two samples from the patient were provided for investigation.The investigation could reproduce the results obtained by the customer.
Additional Manufacturer Narrative
For the two samples provided for investigation, the first sample was the complained sample.This sample had a slightly positive cmv pcr result at 150 copies.The second sample provided for investigation was initially tested by the customer on (b)(6) 2023.This sample resulted in a cmv igm value of 1.06 coi (positive) and a cmv igg value of 0.417 u/ml (negative).On (b)(6) 2023, the patient was measured using the cmv pcr method and the result was positive with 50 copies.A third sample collected from the same patient and tested on (b)(6) 2023 resulted in a toxo igm value of 0.207 coi.This sample had a positive cmv pcr result at 50 copies.

• Brand Name: ELECSYS CMV IGM
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17130598
• Report Number: 1823260-2023-01971
• Device Sequence Number: 15298032
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K163569
• 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,Followup,Followup
• Report Date (Section B): 09/06/2023

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: CMV IGM ELECSYS E2G
• Device Lot Number: ASKU
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 06/19/2023; 07/14/2023; 08/24/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/13/2023; 07/21/2023; 09/06/2023
• 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