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

Catalog Number 06C36-76

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6c36 that has a similar product distributed in the us, list number 4p53.

Event Description

The customer reported a (b)(6) architect (b)(6) result for a patient.The following data was provided on (b)(6) 2021: elisa method = initial result = (b)(6).Autobio instrument result = (b)(6).Architect i2000sr analyzer initial result =(b)(6), repeat after centrifugation = (b)(6).There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for potential false negative architect hbsag results included a search for similar complaints, and review of complaint text, trending data, labeling, and device history records.In-house testing of the complaint lot was completed.Return testing was not completed as returns were not available.Trending review determined no trends were identified for the issue for the product.Device history record review for the complaint lot did not show any non-conformances or deviations.In house testing of sensitivity panels which mimic patient samples was completed using retained samples of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect hbsag assay, lot number 14116fn01 was identified.Corrected information: d.Suspect medical device: d4: lot number: old lot 14116fn00 to new lot 14116fn01.

• 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; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 11174398
• MDR Text Key: 235045954
• Report Number: 3008344661-2021-00011
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: 06C36-76
• Device Lot Number: 14116FN01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• 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)