MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated alinity i anti-hbs results for one patient.The following data was provided (>10.0 miu/ml is considered protected): initial result, on (b)(6), was 247.21, repeat was 253.29 miu/ml.The patient¿s previous result, on (b)(6) was 1.17 miu/ml.There was no impact to patient management reported.

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.Section e1 - phone complete entry = (b)(6).This report is being filed on an international product, list number (b)(4), that has a similar product distributed in the us, list number (b)(4).

Manufacturer Narrative

The complaint investigation for a falsely elevated alinity i anti-hbs result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing.Trending review determined no related trend for the issue for the product.Return testing was not completed, as returns were not available.Specificity testing was performed using an in-house retained kit of lot 47553fn01, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i anti-hbs, lot number 47553fn01, was identified.Section g1 contact information was updated to reflect the current contact (b)(6).

Event Description

The customer observed falsely elevated alinity i anti-hbs results for one patient.The following data was provided (>10.0 miu/ml is considered protected): initial result, on (b)(6), was 247.21, repeat was 253.29 miu/ml.The patient¿s previous result, on(b)(6)was 1.17 miu/ml.There was no impact to patient management reported.

• 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 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17663506
• MDR Text Key: 322423905
• Report Number: 3008344661-2023-00166
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/19/2023

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: 04/13/2024
• Device Catalogue Number: 07P89-77
• Device Lot Number: 47553FN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2023
• 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)