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

Catalog Number 06C36-76

Device Problem High Test Results (2457)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

The customer reported false positive architect hbsag results have skewed high.The customer indicated that the impacted patients have been previously tested and confirmed positive with confirmatory testing for hbsag.There was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 6c36 and there is a similar product distributed in the u.S., list number 4p53.E1 phone number: 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.

Manufacturer Narrative

Additional information received from customer: the customer clarified that the assay was not being used for monitoring hbsag and that the impacted patients have not been previously tested and confirmed positive with confirmatory testing for hbsag.Based upon this new information, this complaint is no longer a reportable event.Additional information updated in fields, b5, h3, and h6 h3 other text : additional information received from customer: the customer clarified that the assay was not being used for monitoring hbsag and that the impacted patients have not been previously tested and confirmed positive with confirmatory testing for hbsag.Based upon this new information, this complaint is no longer a reportable event.

Event Description

The customer reported false positive architect hbsag results have skewed high.The customer indicated that the impacted patients have been previously tested and confirmed positive with confirmatory testing for hbsag.There was no reported impact to patient management.Update: on (b)(6) 2023, the customer clarified that the assay was not being used for monitoring hbsag and that the impacted patients have not been previously tested and confirmed positive with confirmatory testing for hbsag.

• Brand Name: ARCHITECT HBSAG 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: 17343242
• MDR Text Key: 319530415
• Report Number: 3008344661-2023-00129
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06C36-76
• Device Lot Number: 48527FN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• 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
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR64484; ARC I2000SR INST, 03M74-02, ISR64484