MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number 07P51-20

Device Problem False Negative Result (1225)

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

Event Date 07/30/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false negative alinity i total -hcg results on one patient.The result was not reported.The sample was repeated with higher results.The following data was provided: sid (b)(6), (b)(6) 2023 b-hcg result = <2.30 miu/ml repeat result ran (b)(6) 2023 = 51.83 miu/ml no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false negative results when using alinity i total ss-hcg reagent lot number 51620ud00, 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.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Device history record review on lot 51620ud00 did not show any potential non-conformances, deviations, or non-conformances associated with the complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the alinity i total ss-hcg reagent lot number 51620ud00 was identified.

Event Description

The customer observed false negative alinity i total -hcg results on one patient.The result was not reported.The sample was repeated with higher results.The following data was provided: sid (b)(6) 2023 b-hcg result = <2.30 miu/ml repeat result ran (b)(6) 2023 = 51.83 miu/ml no impact to patient management was reported.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17584544
• MDR Text Key: 321593567
• Report Number: 3005094123-2023-00218
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K170317
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2024
• Device Catalogue Number: 07P51-20
• Device Lot Number: 51620UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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)