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

Catalog Number 04P76-30

Device Problem False Positive Result (1227)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 4p76-25/-30/-35 and there is a similar product distributed in the us, list number 4p76-27/-32/-37.A1 patient identifier: complete sample id is (b)(6).E1 phone: complete phone number is (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false non-reactive architect hbsag next qualitative on (b)(6) 2023 and provided data for 1 patient.(reference = 1 s/co is reactive) sample id (b)(6) initial result was 1.20 (reactive), repeat tests were 0.84 (non-reactive) and 0.80 (non-reactive).The customer reported that since the patient has a history of being a hepatitis carrier, the customer performed confirmatory testing with architect hbsag next confirmatory reagent kit, which generated a result of 97.51 (reference = 50% is considered confirmed positive).The customer provided additional laboratory data: hbscf2 was 1.02, anti-hbs was 1, anti-hbc was 9.52.The customer communicated that the discrepant result was not reported out of the laboratory.There was no reported impact to patient management.

Manufacturer Narrative

Sections a2 age and a3 gender updated with additional information received by the customer.

Event Description

The customer reported a false non-reactive architect hbsag next qualitative on (b)(6) 2023 and provided data for 1 patient.(reference = 1 s/co is reactive) sample id (b)(6) initial result was 1.20 (reactive), repeat tests were 0.84 (non-reactive) and 0.80 (non-reactive).The customer reported that since the patient has a history of being a hepatitis carrier, the customer performed confirmatory testing with architect hbsag next confirmatory reagent kit, which generated a result of 97.51 (reference = 50% is considered confirmed positive).The customer provided additional laboratory data: hbscf2 was 1.02, anti-hbs was 1, anti-hbc was 9.52.The customer communicated that the discrepant result was not reported out of the laboratory.There was no reported impact to patient management.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in house testing of a retained reagent kit lot 43255fn00.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot did not identify an increase in complaint activity.Ticket trending review did not identify any trends regarding commonalities for complaint lot.Device history review did not identify any non-conformances or deviations with the complaint lot.In house testing was completed using panels which mimic patient samples using an in-house retained kit.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect hbsag next qualitative reagent lot 43255fn00 was identified.

• Brand Name: ARCHITECT HBSAG NEXT QUALITATIVE REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; 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: 17242734
• MDR Text Key: 318489497
• Report Number: 3008344661-2023-00124
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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,Followup
• Report Date: 08/15/2023

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 Expiration Date: 12/02/2023
• Device Catalogue Number: 04P76-30
• Device Lot Number: 43255FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/04/2023; 08/01/2023
• Supplement Dates FDA Received: 07/06/2023; 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Age: 59 YR
• Patient Sex: Male