MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I HBSAG CONFIRMATORY V.1 REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 08P09-22

Device Problem False Negative Result (1225)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 8p09 that has a similar product distributed in the us, list number 4p54.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a false negative alinity i hbsag confirmatory result for a patient who was repeatedly reactive when tested with the hbsag screening assay.The following data was provided for the confirmatory testing: undiluted reagent2 = 1.37 s/co neutralization rate = 19.37% 500-fold diluted reagent2 = 0.79 s/co neutralization rate = 76.32% the customer was questioning the negative 500-fold dilution results.The customer was expecting the patient's confirmatory testing to be confirmed positive because the patient was repeatedly reactive when tested with the screening assay.There is no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false negative alinity i hbsag confirmatory results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket tracking and trending was reviewed for the list number and did not identify any trends regarding the commonalities for the complaint issue.The device history record was reviewed and did not identify any non-conformances, potential non-conformances, or deviations associated with the list number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for the alinity i hbsag confirmatory reagent kit list number 08p09-22, lot unknown.

Event Description

The customer observed a false negative alinity i hbsag confirmatory result for a patient who was repeatedly reactive when tested with the hbsag screening assay.The following data was provided for the confirmatory testing: undiluted reagent2 = 1.37 s/co neutralization rate = 19.37% 500-fold diluted reagent2 = 0.79 s/co neutralization rate = 76.32% the customer was questioning the negative 500-fold dilution results.The customer was expecting the patient's confirmatory testing to be confirmed positive because the patient was repeatedly reactive when tested with the screening assay.There is no impact to patient management reported.

• Brand Name: ALINITY I HBSAG CONFIRMATORY V.1 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: 19043417
• MDR Text Key: 340115842
• Report Number: 3008344661-2024-00041
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00380740130503
• UDI-Public: (01)00380740130503
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/19/2024

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 Catalogue Number: 08P09-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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).