• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT IRELAND ARCHITECT HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) Back to Search Results
Catalog Number 06C36-76
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This report is being filed on an international product, architect (b)(6), list 6c36, that has a similar product distributed in the us, list number 4p53. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. Additional information section 1 patient information: patient 1 - (b)(6) year old male. Patient 2 - (b)(6) year old male. Patient 3 - (b)(6) year old male. Patient 4 - (b)(6) year old female.
 
Event Description
The customer obtained false negative architect (b)(6) results for four samples. The customer indicated the samples were positive for dna. The following results were provided: patient 1 - (b)(6) year old male with chronic (b)(6): 0 and 0. 01 iu/ml on two architect analyzers and 0 iu/ml on alinity (b)(6). Patient 2 - (b)(6) year old male with liver fibrosis: 0. 04 and 0. 02 iu/ml on two architect analyzers; alinity (b)(6). Patient 3 - (b)(6) year old male with liver transplant: 0 and 0 iu/ml on two architect analyzers and 0 iu/ml on alinity (b)(6). Patient 4 - (b)(6) year old female with chronic (b)(6): 0. 03 and 0. 02 iu/ml on two architect analyzers and 0. 02 iu/ml on the alinity (b)(6). No impact to patient management was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCHITECT HBSAG REAGENT KIT
Type of DeviceTEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
Manufacturer (Section D)
ABBOTT IRELAND
finisklin business park
sligo F91VY 44
EI F91VY44
Manufacturer (Section G)
ABBOTT IRELAND
finisklin business park
sligo F91VY 44
EI F91VY44
Manufacturer Contact
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key10823560
MDR Text Key249659836
Report Number3008344661-2020-00107
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeCH
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 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2021
Device Catalogue Number06C36-76
Device Lot Number14116FN00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-