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 07/23/2023

Event Type  malfunction  

Manufacturer Narrative

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).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.

Event Description

The customer stated that falsely decreased alinity i toal b-hcg results of <2.3 miu/ml were generated for a patient sample.The following data was provided.(b)(6).Initial result: < 2.3 miu/ml (negative).Retest result (same day): <2.3 miu/ml (negative).Retest the following day (as the patient report stated that a home test was weakly positive): 16.28 miu/ml (grayzone).The sample was sent to another laboratory for testing using the roche b-hcg method and the result was positive at 13.5 miu/ml.No impact to patient management was reported.

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, device history record review, and in house testing of a retained reagent kit, lot 45177ud00.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.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.In-house testing was completed using panels which mimic patient samples using an in-house retained kit.All specifications were met, indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i total b-hcg reagent lot 45177ud00 was identified.

Event Description

The customer stated that falsely decreased alinity i toal b-hcg results of <2.3 miu/ml were generated for a patient sample.The following data was provided.Sid (b)(6).Initial result: < 2.3 miu/ml (negative) retest result (same day): <2.3 miu/ml (negative) retest the following day (as the patient report stated that a home test was weakly positive): 16.28 miu/ml (grayzone).The sample was sent to another laboratory for testing using the roche b-hcg method and the result was positive at 13.5 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: 17543478
• MDR Text Key: 321144413
• Report Number: 3005094123-2023-00215
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2023
• Device Catalogue Number: 07P51-20
• Device Lot Number: 45177UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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 Sex: Female