MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07P89-77

Device Problem High Test Results (2457)

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

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 07p89 that has a similar product distributed in the us, list number 07p88.All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported (b)(6) alinity i (b)(6) results on a (b)(6) year-old female with a clinical diagnosis of (b)(6).The results from sample collected on (b)(6) 2020 were: alinity i (b)(6).Other results provided: (b)(6).No impact to patient management was reported.

Manufacturer Narrative

H6 health effect impact code: f26.H6 component code: g01003.D8: was this device serviced by a third party? unknown.The complaint investigation included a search for similar complaints, and the review of the complaint text, trending data, labelling, and device history records.Return testing was not completed as returns were not available.Clinical specificity testing was performed.The lot search review did not identify an increase in complaint activity for the issue of false positive patient results.A review of tracking and trending did not identify any trend regarding commonalities for lot number and complaint issue.Device history record review did not identify any issues associated with lot 19105fn01 and the complaint issue.Performance testing was performed using an in-house retained sample of the complaint lot.All acceptance criteria were met indicating the lot is performing as expected.The overall specificity for the alinity i anti-hbs assay (determined by considering result values of = 10.00 miu/ml as reactive and result values of < 10.00 miu/ml as nonreactive) was estimated to be 99.76% (for total donors) and 98.32% (for hospitalized patients) at the lower 95% confidence level, therefore false reactive results may at times occur.False elevated results may arise as a result of sample or reagent integrity issues at time of testing and details regarding sample and reagent handling are provided within the product package insert.For accurate results, serum and plasma specimens should be free of fibrin, red blood cells, and other particulate matter.To ensure consistency in results, re-centrifuge specimens prior to testing if they contain fibrin, red blood cells, or other particulate matter.A review of the labelling and literature addresses the customer¿s issue.Per product labelling, if the anti-hbs results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute, chronic, or recovered infection.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs assay, lot number 19105fn01 was identified.Corrected data found in field d4.Lot number was changed from 19105fn00 to 19105fn01 and list number was changed from 07p89-32 to 07p89-77.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field.H10.There is no change to the content of the data.

Manufacturer Narrative

This follow-up is being submitted to correct data in field d4 catalog no (from 07p89-32 to 07p89-77) and d4 lot no (from 19105fn00 to 19105fn01).

• Brand Name: ALINITY I ANTI-HBS 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: 11018851
• MDR Text Key: 251888600
• Report Number: 3008344661-2020-00138
• 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,Followup,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Catalogue Number: 07P89-77
• Device Lot Number: 19105FN01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 40 YR