MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT CMV IGG REAGENT KIT; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number 06C15-30

Device Problem False Positive Result (1227)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

The customer observed false reactive architect cmv igg result for a patient which was questioned by the physician.The following data was provided: cmv igg result = 250 au/ml (reactive).Cmv igm result = negative.Per the architect cmv igg package insert, interpretation of results section: specimens with concentration values = 6.0 au/ml are considered reactive for igg antibodies to cmv and indicate past or acute infection.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for false reactive architect cmv igg result included a review of data and information provided by the customer, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause list number and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.It is possible that the false positive cmv igg result obtained on the architect platform may been due to reagent/sample integrity issues at the time of testing.Details around specimen handling are outlined in the product package insert.Per product labelling, specimens which are heat-inactivated, pooled, grossly hemolyzed (> 500 mg/dl hemoglobin) or have obvious microbial contamination should not be used with this assay.For accurate results, serum and plasma specimens should be free of fibrin, red blood cells, or other particulate matter.Serum specimens from patients receiving anticoagulant or thrombolytic therapy may contain fibrin due to incomplete clot formation.To prevent cross contamination, use of disposable pipettes or pipette tips is recommended.All samples (calibrators, controls, and patient specimens) should be tested within 3 hours of being placed on board the architect isystem.Based on this investigation, no systemic issue or deficiency with the architect cmv igg reagent was identified.

Event Description

The customer observed false reactive architect cmv igg result for a patient which was questioned by the physician.The following data was provided: cmv igg result = 250 au/ml (reactive).Cmv igm result = negative.Per the architect cmv igg package insert, interpretation of results section: specimens with concentration values = 6.0 au/ml are considered reactive for igg antibodies to cmv and indicate past or acute infection.No impact to patient management was reported.

• Brand Name: ARCHITECT CMV IGG REAGENT KIT
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17244189
• MDR Text Key: 318343802
• Report Number: 3008344661-2023-00126
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K220949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06C15-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• 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
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR51766; ARC I2K PROC MOD, 03M74-01, ISR51766