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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY; HBSAG CONFIRMATORY
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ABBOTT IRELAND ARCHITECT HBSAG QUALITATIVE CONFIRMATORY; HBSAG CONFIRMATORY Back to Search Results
Catalog Number 04P54-25
Medical Device Problem Code False Positive Result (1227)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/16/2019
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
The customer reported a false repeat reactive architect hbsag result on one patient.Results provided: (b)(6) = 1.81 / 1.75 / 1.73 s/co, confirmed positive by (b)(6) neutralizing confirmatory assay ((b)(6) = 1.57 s/co, (b)(6) %n = 100%).The physician questioned the result, sample was sent out for additional testing that produced a negative result.No impact to patient management was reported.
 
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Brand Name
ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
Common Device Name
HBSAG CONFIRMATORY
Manufacturer (Section D)
ABBOTT IRELAND
diagnostics division
finisklin business park
sligo NA
EI  NA
MDR Report Key9354161
Report Number3008344661-2019-00137
Device Sequence Number19356176
Product Code LOM
UDI-Device Identifier00380740007799
UDI-Public00380740007799
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P110029
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/21/2019
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
Operator of Device Health Professional
Device Catalogue Number04P54-25
Device Lot Number03278FN00
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/05/2019
Initial Report FDA Received Date11/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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