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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) Back to Search Results
Catalog Number 07P89-57
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The customer observed false reactive alinity i anti-hbs results with new lot number of reagent and calibrator that negative on another alinity i processing module for multiple patients.The results provided were: patient 4: initial=12.32 miu/ml (>or =10 miu/ml consider being protective against hepatitis b viral infection) /repeated on another alinity i processing module=7.4 miu/ml patient 6: initial=14.39 miu/ml /repeated on another alinity i processing module=9.2 miu/ml there was no reported impact to patient management.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed false reactive alinity i anti-hbs results with new lot number of reagent and calibrator that negative on another alinity i processing module for multiple patients.The results provided were: patient 4: initial=12.32 miu/ml (>or =10 miu/ml consider being protective against hepatitis b viral infection) /repeated on another alinity i processing module=7.4 miu/ml patient 6: initial=14.39 miu/ml /repeated on another alinity i processing module=9.2 miu/ml there was no reported impact to patient management.
 
Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data and retained kit testing of alinity i anti-hbs reagent lot 53052fn00.The evaluation of complaint data for the product and likely cause alinity i anti-hbs reagent lot 53052fn00 identified as expected activity.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.Inhouse testing determined that the sensitivity performance of lot 53052fn00 testing met acceptance criteria indicating the product is performing as expected.Per product labelling, if the anti-hbs results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute, chronic, or recovered infection.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i anti-hbs assay lot number 53052fn00.
 
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Brand Name
ALINITY I ANTI-HBS REAGENT KIT
Type of Device
TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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 Key18291194
MDR Text Key330830903
Report Number3008344661-2023-00195
Device Sequence Number1
Product Code LOM
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
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 02/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07P89-57
Device Lot Number53052FN00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
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