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

Catalog Number CMV IGM ELECSYS E2G

Device Problem False Negative Result (1225)

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

Event Date 05/16/2023

Event Type  malfunction  

Event 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).

Manufacturer Narrative

The sample was requested for investigation.

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.

Manufacturer Narrative

Two samples from the patient were provided for investigation.The investigation could reproduce the results obtained by the customer.

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
• Type of Device: 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
• MDR Text Key: 317505756
• Report Number: 1823260-2023-01971
• Device Sequence Number: 1
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K163569
• 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,Followup,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/24/2023
• 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