MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY S HBSAG

Catalog Number 06P02-55

Device Problem High Test Results (2457)

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

Event Date 04/08/2019

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, alinity hbsag, list 06p02-55, that has a similar product distributed in the us, list 06p02-60.

Event Description

The customer observed a (b)(6) hbsag result on the alinity s analyzer.The following data was provided: (b)(6).Hbsag prism initial test: (b)(6), hbsag prism retest 1: (b)(6), hbsag prism retest 2: (b)(6), ahbc architect: (b)(6), ahbs architect: (b)(6), nat ct hbv (roche): (b)(6), viral load: (b)(6), alinity s hbsag: (b)(6).There was no impact to patient management reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and sensitivity testing.No adverse trend was identified for the customer's issue.The customer declined to send the sample at this time.Labeling was reviewed and found to be adequate.Both clinical seroconversion panels and in-house sensitivity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

Manufacturer Narrative

Correction to section d.Medical device information 1.Brand name from alinity hbsag to alinity s hbsag; 2.Product code from ksj to qhm.Update to h6 method code to include 4106 update to the investigation: further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and sensitivity testing.No adverse trend was identified for the customer's issue.The customer declined to send the sample at this time.Labeling was reviewed and found to be adequate.Both clinical seroconversion panels and in-house sensitivity testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.Update: 16sep2020 the return sample was tested with the prism hbsag confirmatory test only, due to limited sample volume provided by the customer.The customer obtained repeat reactive results with prism hbsag assay, but no test with prism hbsag confirmatory had been performed.Alinity s hbsag gave nonreactive results at the customer site.Testing of the prism hbsag confirmatory was performed to see if the repeat reactive results obtained with prism hbsag assay are specific to hbsag.The sample was confirmed positive with the prism hbsag confirmatory assay.Therefore, discrepant results were obtained to the nonreactive results obtained by the customer with alinity s hbsag.The overall outcome of the initial investigation did not change.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified for the alinity s hbsag reagent, lot number 93169fn00.

• Brand Name: ALINITY S HBSAG
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 8995120
• MDR Text Key: 160057610
• Report Number: 3008344661-2019-00114
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2020

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: 10/30/2019
• Device Catalogue Number: 06P02-55
• Device Lot Number: 93169FN00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 09/16/2020
• Supplement Dates FDA Received: 12/19/2019; 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY S ANALYZER, LIST 06P16-01; ALINITY S ANALYZER, LIST 06P16-01; ALINITY S ANALYZER, LIST 06P16-01; SERIAL (B)(6) ; SERIAL (B)(6) ; SERIAL (B)(6)