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 07P89-74

Device Problem High Test Results (2457)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 07p89-74 and there is a similar product distributed in the us, list number 7p88.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false elevated alinity i anti-hbs and provided the following data: the anti-hbs result was 52.82 miu/ml and repeat was 49.84 miu/ml (reference: based on the world health organization recommendation, an antihbs concentration = 10 miu/ml is regarded as being protective) the customer tested the sample on the maccura platform, and the result was negative (no value provided); the colloidal gold result was negative.Additional laboratory information: hbsag/hbeag/anti-hbc were positive.The customer confirmed that they are not questioning any of the additional laboratory results.Patient information: 58 year-old man, clinically diagnosed with a remote rib fracture.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.There was no reported impact to patient management.

Manufacturer Narrative

The complaint investigation included a review of data and information provided by the customer, search for similar complaints, trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not yet available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review for the complaint lot did not identify any non-conformances or deviations associated with the customer reported issue.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Trending review has not identified any trends.The overall performance of alinity i anti-hbs was reviewed using field data from customers.The review found that the patient median result is comparable with all other lots in the field and within established baselines, confirming no systemic issue.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity i anti-hbs reagent lot 51253fn01.

Event Description

The customer reported false elevated alinity i anti-hbs and provided the following data: the anti-hbs result was 52.82 miu/ml and repeat was 49.84 miu/ml (reference: based on the world health organization recommendation, an antihbs concentration = 10 miu/ml is regarded as being protective) the customer tested the sample on the maccura platform, and the result was negative (no value provided); the colloidal gold result was negative.Additional laboratory information: hbsag/hbeag/anti-hbc were positive.The customer confirmed that they are not questioning any of the additional laboratory results.Patient information: 58 year-old man, clinically diagnosed with a remote rib fracture.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.There was no reported impact to patient management.

• 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: 18898492
• MDR Text Key: 337621731
• Report Number: 3008344661-2024-00035
• 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
• Report Date: 05/30/2024

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: 07P89-74
• Device Lot Number: 51253FN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• 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)
• Patient Age: 58 YR
• Patient Sex: Male