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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE II
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ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE II Back to Search Results
Catalog Number 02G22-25
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2020
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
The customer reported a false repeat reactive architect hbsag result on a newborn patient.Results provided: (b)(6) 2020 sid (b)(6) = 5.14 s/co, (b)(6) 2020 sid (b)(6) = 2.47 / 2.23 s/co.Sample was sent for confirmatory testing and was positive.The mother was tested and was negative on (b)(6) 2020 sid (b)(6) = 0.14 s/co.No impact to patient management was reported.
 
Manufacturer Narrative
The complaint investigation for potential false reactive and confirmed positive hbsag results included a search for similar complaints, and review of complaint text, instrument result logs, trending data, labeling, and device history records.In-house testing and return testing of reagent lot 04338fn00 was not completed as the reagent kit has expired.Trending review determined no trends for the issue for the products.Device history record review on lots 07389fn00 & 04338fn00 did not show any potential non-conformances, or deviations related to the customer's issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect hbsag qualitative ii assay, lot number 07389fn00 & architect hbsag qualitative ii confirmatory assay, lot number 04338fn00 was identified.See mr# 3008344661-2020-00041 for architect hbsag qualitative ii confirmatory assay, lot number 04338fn00 submission.
 
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Brand Name
ARCHITECT HBSAG QUALITATIVE II
Type of Device
HBSAG
Manufacturer (Section D)
ABBOTT IRELAND DIAGNOSTICS DIVISION
finisklin business park
diagnostics division
sligo NA
EI  NA
MDR Report Key10091785
MDR Text Key208218226
Report Number3008344661-2020-00040
Device Sequence Number1
Product Code LOM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/26/2020
Device Catalogue Number02G22-25
Device Lot Number07389FN00
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/25/2020
Initial Date FDA Received05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I1000SR ANALYZER LIST 01L86-01; ARCHITECT I1000SR ANALYZER LIST 01L86-01; LIST 02G23-40 LOT 04338FN00; LOT 04338FN00; SERIAL (B)(6) HBSAG CONFIRM; SERIAL (B)(6) HBSAG CONFIRM LIST 02G23-40
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