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 08/10/2022

Event Type  malfunction  

Event Description

The customer observed false reactive architect hbsag qualitative ii results on one patient.The following results provided were from two tubes on same patient: initial=3.95 s/co (> or = 1.00 s/co=reactive) /repeated=2.89 s/co /neutralizing confirmatory; c2=1.95 s/co (> or = 0.70 s/co); %neutralization=99.9% (> or = 50%=confirmed positive)/ send out second tube to other facility=0.01 s/co (< 1.00 s/co=nonreactive) /repeated=0.32 s/co /repeated original tube at customer site=0.92 s/co and 0.87 s/co.There was no reported impact to patient management.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for false reactive architect hbsag qualitative ii confirmatory results included a search for similar complaints, and review of the complaint text, trending data, labelling, device history records of architect hbsag qualitative ii confirmatory lot unknown.A lot search was not performed as the likely cause lot is unknown.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect hbsag qualitative ii confirmatory reagent, lot unknown.

• 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: 15419195
• MDR Text Key: 300462965
• Report Number: 3008344661-2022-00109
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• 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
• Date Manufacturer Received: 10/18/2022
• 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, 37522FN00; ARC HBSAG QUAL II (100T, 02G22-25, 37522FN00; ARC I1000SR INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)