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 Problems False Positive Result (1227); High Test Results (2457)

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

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Event Description

The customer questioned a reactive alinity i anti-hbs result for a 37 year old male patient diagnosed with liver disease and spleen deficiency.Hbsag: >(b)(6) u/ml, reference range: 0-0.05iu/ml, reactive.Anti-hbs: (b)(6) miu/ml, reference range: 0-10 miu/ml, reactive (protective against hepatitis b viral infection).Hbeag: (b)(6) s/co, reference range: 0-1 s/co, nonreactive.Anti-hbe: (b)(6) s/co, reference range: >1 s/co, reactive.Anti-hbc:(b)(6) s/co, reference range: 0-1 s/co, reactive.The customer retested the sample using an elisa method, and results were reactive only for hbsag, anti-hbe and anti-hbc.There was a discrepancy in anti-hbs and hbeag results across platforms.No adverse impact to patient management was reported.

Manufacturer Narrative

Information provided by the customer was reviewed and supports the complaint issue without indication for any additional issue.Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.Worldwide data from abbottlink was reviewed and determined that patient median result for the lot is comparable with other lots in the field and within established baselines confirming no systemic issue for the lot.Based on the investigation, no deficiency for lot number 30022fn01 was identified.

Manufacturer Narrative

It was discovered upon quality review on may 12, 2022 that the incorrect medical device problem code was entered for this incident in section h6.The code has been corrected from (b)(6).

• 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
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 13228240
• MDR Text Key: 290148060
• Report Number: 3008344661-2022-00003
• 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,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Catalogue Number: 07P89-77
• Device Lot Number: 30022FN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: No
• 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).
• Patient Age: 37 YR
• Patient Sex: Male