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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
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ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE II REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) Back to Search Results
Catalog Number 02G22-25
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2023
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 2g22 that has a similar product distributed in the us, list number 4p53.
 
Event Description
A journal article by marina bubonja-sonjea,dolores peru, maja abram, bojana mohar-vitezi.¿prevalence of occult hepatitis b virus infection and characterisation of hepatitis b surface antigen mutants among adults in western croatia¿, annals of hepatology, volume 29, issue 1, january¿february 2024, 101156.Documented false positive architect anti-hbc ii and false negative architect hbsag qualitative ii results.No impact to patient management was reported.
 
Event Description
A journal article by marina bubonja-sonjea,dolores peru, maja abram, bojana mohar-vitezi.¿prevalence of occult hepatitis b virus infection and characterisation of hepatitis b surface antigen mutants among adults in western croatia¿, annals of hepatology, volume 29, issue 1, january¿february 2024, 101156.Documented false positive architect anti-hbc ii and false negative architect hbsag qualitative ii results.No impact to patient management was reported.
 
Manufacturer Narrative
The complaint investigation was performed for false nonreactive results with the architect hbsag qualitative ii assay (lot# unknown) which included a review of data and information provided in the article, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review determined no 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.The overall performance of architect hbsag qualitative ii reagents in the field was reviewed using data gathered from customers worldwide and suggested that the performance is acceptable.Labeling review concluded that the issue is adequately addressed.Based on our investigation, no systemic issue or product deficiency of the architect hbsag qualitative ii reagent was identified.
 
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Brand Name
ARCHITECT HBSAG QUALITATIVE II 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 Key18186688
MDR Text Key328747229
Report Number3008344661-2023-00194
Device Sequence Number1
Product Code LOM
Combination Product (y/n)N
Reporter Country CodeHR
PMA/PMN Number
P110029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number02G22-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2024
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 Number1
Treatment
ARC I1000SR MOD, 01L86-01, 117 UNKNOWN SN#; ARC I1000SR MOD, 01L86-01, 117 UNKNOWN SN#
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