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

Catalog Number 07P42-32

Device Problem False Negative Result (1225)

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

Event Date 01/07/2024

Event Type  malfunction  

Event Description

The customer observed false nonreactive alinity i cmv igg results for one patient.The sample was repeated three more times and a reactive result was obtained.The following data was provided: sid (b)(6): first run (1:10 dilution) = <11 au/ml, second run (undiluted) = >250 au/ml, third run (1:10 dilution) = <11 au/ml, fourth run (1:10 dilution) = 600 au/ml.Per the alinity i cmv igg package insert, interpretation of results section: specimens with concentration values = 6.0 au/ml are considered reactive and < 6.0 au/ml are considered nonreactive.There was no impact to patient management reported.

Manufacturer Narrative

This report is being filed on an international product, alinity i cmv igg, list number 07p42-32, that has a similar product distributed in the us, list number 7p42-24/-33.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i cmv igg results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Additionally, in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with the lot number 51601fn00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Furthermore, clinical sensitivity testing was performed using an in-house retained reagent kit of the complaint lot.All specifications were met which indicates the lot is performing as expected.Based on our investigation, no systemic issue or deficiency with the alinity i cmv igg reagent for lot 51601fn00 was identified.

Event Description

The customer observed false nonreactive alinity i cmv igg results for one patient.The sample was repeated three more times and a reactive result was obtained.The following data was provided: sid (b)(6): first run (1:10 dilution) = <11 au/ml second run (undiluted) = >250 au/ml third run (1:10 dilution) = <11 au/ml fourth run (1:10 dilution) = 600 au/ml per the alinity i cmv igg package insert, interpretation of results section: specimens with concentration values = 6.0 au/ml are considered reactive and < 6.0 au/ml are considered nonreactive.There was no impact to patient management reported.

• Brand Name: ALINITY I 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18603485
• MDR Text Key: 334495598
• Report Number: 3008344661-2024-00013
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: KZ
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P42-32
• Device Lot Number: 51601FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)