MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY S HBSAG REAGENT KIT; ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND IGM)

Catalog Number 06P02-60

Device Problem False Positive Result (1227)

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

Event Date 11/02/2023

Event Type  Injury  

Event Description

The customer reported false reactive alinity s hbsag assay on cadaveric samples and provided the following information: reference = 1.0 s/co is reactive.On (b)(6) 2023, sample id (b)(6) initial result was 1.57 (reactive) and repeat results were 1.46 (reactive) & 1.26 (reactive).Nat result was negative.Tissue status: discarded patient information: 3-month-old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination status was unknown, however the patient had 2 months of unspecified vaccines.Donor tissue discarded.

Manufacturer Narrative

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

Manufacturer Narrative

Section h3 was updated to indicate an evaluation is still in process.Section d4 - lot # was corrected h3 other text : an evaluation is still in process.

Event Description

The customer reported false reactive alinity s hbsag assay on cadaveric samples and provided the following information: reference = 1.0 s/co is reactive on (b)(6) 2023, sample id (b)(6) initial result was 1.57 (reactive) and repeat results were 1.46 (reactive) & 1.26 (reactive).Nat result was negative.Tissue status: discarded patient information: 3-month-old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination status was unknown, however the patient had 2 months of unspecified vaccines.Donor tissue discarded.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review, and field data review.Return testing was not completed 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.Device history review did not identify any potential non-conformances, non-conformances, or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint issue.The ticket trending review did not identify any trends.The overall performance of the alinity s hbsag reagent was reviewed using field data from customers.A review of field data for the overall performance of lot 50489fn00 indicated the product was performing within product requirements.Labeling was reviewed and was found to address the customer reported issue.Based on the results of the investigation, alinity s hbsag reagent, lot number 50489fn00 met performance requirements and no systemic issue or product deficiency was identified.

Event Description

The customer reported false reactive alinity s hbsag assay on cadaveric samples and provided the following information: reference = 1.0 s/co is reactive.On (b)(6) 2023, sample id (b)(6) initial result was 1.57 (reactive) and repeat results were 1.46 (reactive) & 1.26 (reactive).Nat result was negative.Tissue status: discarded patient information: 3-month-old male who was found unresponsive at home.Information regarding medications: 4 doses of epinephrine.Hepatitis b vaccination status was unknown, however the patient had 2 months of unspecified vaccines.Donor tissue discarded.

• Brand Name: ALINITY S HBSAG REAGENT KIT
• Type of Device: ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGG AND 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: 18142999
• MDR Text Key: 328196776
• Report Number: 3008344661-2023-00188
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BL 125674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Catalogue Number: 06P02-60
• Device Lot Number: 50489FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 11/28/2023; 12/20/2023
• Supplement Dates FDA Received: 12/14/2023; 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01, (B)(6); ALNTY S SYSTEM, 06P16-01,(B)(6)
• Patient Outcome(s): Disability
• Patient Age: 3 MO
• Patient Sex: Male