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

Catalog Number 02G23-25

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Event Description

The customer observed false repeat reactive architect hbsag qualitative ii results on one patient from two different specimens.The results provided were: on (b)(6) 2022, sid (b)(6).First specimen initial=180.21 s/co (> or =1.00 s/co=reactive) /repeated=146.35 s/co /repeated by elfa method=reactive /hbsag confirmation=reactive (no actual results provided).Second specimen initial=0.26 s/co (< 1.00 s/co=nonreactive) /repeated=0.25 s/co.There was no reported impact to patient management.

Manufacturer Narrative

Complete information for patient information 1.Patient identifier= sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Additional information provided on 05jan2022: the customer used hbsag confirmatory list number 4p77 which is not approved in the us.This report is being filed on an international product, list number 4p77-25 that has a no similar product distributed in the us, therefore no mdr was generated.

Event Description

The customer observed false repeat reactive architect hbsag qualitative ii results on one patient from two different specimens.The results provided were: on 09dec2022 sid (b)(6) first specimen initial=180.21 s/co (> or =1.00 s/co=reactive) /repeated=146.35 s/co /repeated by elfa method=reactive /hbsag confirmation performed at another reference laboratory prodia on (b)(6) =reactive (no actual results provided) second specimen initial=0.26 s/co (< 1.00 s/co=nonreactive) /redrawn and repeated=0.25 s/co there was no reported impact to patient management.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT
• Type of Device: TEST, 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16094567
• MDR Text Key: 307224317
• Report Number: 3008344661-2023-00002
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P110029
• Number of Events Reported: 1
• 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: 01/05/2023

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 Catalogue Number: 02G23-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/05/2023
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ARC HBSAG QUAL II (100T, 02G22-25, 39057FN00; ARC HBSAG QUAL II (100T, 02G22-25, 39057FN00; ARC I1000SR INTGR, 01L86-40, I1SR61188; ARC I1000SR INTGR, 01L86-40, I1SR61188