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

Catalog Number 07P42-22

Device Problem False Negative Result (1225)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

Section a1 - patient identifier: sids = (b)(6).This report is being filed on an international product, alinity i cmv igg, list number 07p42-22, that has a similar product distributed in the us, list number 07p42-24/-33.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false nonreactive alinity i cmv igg result for a pregnant female patient.The patient underwent testing at another facility and the result was reactive.The patient returned on (b)(6) 2023 and repeat testing was performed.The alinity i cmv igg result was still nonreactive.The following data was provided: patient 2: (b)(6) 2023, sid (b)(6), cmv igg result = 0.3 au/ ml (nonreactive).(b)(6) 2023, sid (b)(6), cmv igm result = 0.26 index (nonreactive).Cmv igg result from another facility = reactive.(b)(6) 2023, sid (b)(6), cmv igg result= 0.4 au/ml (nonreactive).(b)(6) 2023, sid (b)(6), cmv igm result= 0.27 index (nonreactive).No impact to patient management was reported.

Event Description

The customer observed false nonreactive alinity i cmv igg result for a pregnant female patient.The patient underwent testing at another facility and the result was reactive.The patient returned on (b)(6) 2023 and repeat testing was performed.The alinity i cmv igg result was still nonreactive.The following data was provided: patient 2: (b)(6) 2023 sid (b)(6) cmv igg result = 0.3 au/ ml (nonreactive).(b)(6) 2023 sid (b)(6) cmv igm result = 0.26 index (nonreactive).Cmv igg result from another facility = reactive.(b)(6) 2023 sid (b)(6) cmv igg result= 0.4 au/ml (nonreactive).(b)(6) 2023 sid (b)(6) cmv igm result= 0.27 index (nonreactive).No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false nonreactive alinity i cmv igg result 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.In-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the reagent lot performs as expected for this product.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 lot number 47298fn00 and complaint issue.Labeling was reviewed and found to be adequate.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 47298fn00 was identified.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17341304
• MDR Text Key: 319277664
• Report Number: 3008344661-2023-00128
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2023
• Device Catalogue Number: 07P42-22
• Device Lot Number: 47298FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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, AI21321.; ALNTY I PROCESSING MODU, 03R65-01, AI21321.
• Patient Sex: Female