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 06C36-29

Device Problem False Negative Result (1225)

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

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed a false nonreactive architect hbsag result generated on the architect i2000sr processing module for 1 patient that was positive a month before using another method.The following results were provided: (b)(6) 2022 cleia method = 0.009 iu/ml positive at a clinic.Architect result = nonreactive there was no reported impact to patient management.

Manufacturer Narrative

Additional information in section b5 :the account provided new additional information on (b)(6)2023 which makes the previously reported issue non-reportable.The customer is no longer questioning the abbott product.The customer believes the negative result from the architect to be correct as it matches dna pcr testing which was also negative(less than 1.0).No impact to patient management was reported.Based upon this new information, this complaint is no longer a reportable event and no further followup will be provided.H3 other text : the account provided new additional information on (b)(6)2023 which makes the previously reported issue non-reportable.The customer is no longer questioning the abbott product.The customer believes the negative result from the architect to be correct as it matches dna pcr testing which was also negative(less than 1.0).No impact to patient management was reported.Based upon this new information, this complaint is no longer a reportable event and no further followup will be provided.

Event Description

The customer observed a false nonreactive architect hbsag result generated on the architect i2000sr processing module for 1 patient that was positive a month before using another method.The following results were provided: (b)(6)2022 cleia method = 0.009 iu/ml positive at a clinic architect result = nonreactive additional information provided (b)(6)2023 the customer is no longer questioning the abbott product.The customer believes the negative result from the architect to be correct as it matches dna pcr testing which was also negative(less than 1.0).There was no reported impact to patient management.

• 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: 17825289
• MDR Text Key: 324363773
• Report Number: 3008344661-2023-00170
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06C36-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• 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 I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)