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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I CMV IGG REAGENT KIT; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
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ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I CMV IGG REAGENT KIT; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS Back to Search Results
Catalog Number 07P42-23
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2023
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 07p42-23, that has a similar product distributed in the us, list number 07p42--24/-33.
 
Event Description
The customer observed false nonreactive alinity i cmv igg results for one patient.The following data was provided: initial result, on 10may, was negative; the cmv igm result was positive.The patient was recollected two weeks later, and the result was negative, the cmv igm result was positive.There was no impact to patient management reported.
 
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, labeling review, device history record review, and testing of retained reagent kits of the complaint lot number.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Sensitivity testing was performed using an in-house retained kit of lot 44231fn00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i cmv igg, lot number 44231fn00, was identified.
 
Event Description
The customer observed false nonreactive alinity i cmv igg results for one patient.The following data was provided: initial result, on 10may, was negative; the cmv igm result was positive.The patient was recollected two weeks later, and the result was negative, the cmv igm result was positive.There was no impact to patient management reported.
 
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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 Key17222054
MDR Text Key318318851
Report Number3008344661-2023-00121
Device Sequence Number1
Product Code LFZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
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 Received06/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/20/2023
Device Catalogue Number07P42-23
Device Lot Number44231FN00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY I PROCESSING MODU, 03R65-01, AI05086; ALNTY I PROCESSING MODU, 03R65-01, AI05086
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