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

Catalog Number	07P51-21
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The customer observed false negative alinity i total -hcg results for one 23-year-old female patient on the alinity i serial number: (b)(6).The sample was repeated with higher results (positive).The patient's urine pregnancy test was positive.The following data was provided: processed on (b)(6) 2026, sid: (b)(6) initial result = <2.42 miu/ml repeat result = 24329.62 miu/ml repeated on another alinity (serial number: (b)(6) = 25826.98 no impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity i total b-hcg reagent, lot 76210ud00.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history review did not identify any nonconformances, potential nonconformances, or deviations associated with the complaint lot.Accuracy testing was completed with a retained kit of the complaint lot.All specifications were met indicating the lot is performing as expected.Labeling was reviewed and adequately addresses the issue.Based on the investigation, there is no systemic issue or deficiency of the alinity i total b-hcg reagent, lot 76210ud00.
Event or Problem Description
The customer observed false negative alinity i total -hcg results for one 23 year old female patient on the alinity i serial number (b)(6).The sample was repeated with higher results(positive).The patient's urine pregnancy test was positive.The following data was provided: processed on (b)(6) 2026 sid (b)(6) initial result = <2.42 miu/ml repeat result = 24329.62 miu/ml, repeated on another alinity (serial number (b)(6)) = 25826.98.No impact to patient management was reported.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Common Device Name: 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23995735
• Report Number: 3005094123-2026-00007
• Device Sequence Number: 13317579
• Product Code: DHA
• UDI-Device Identifier: 00380740160616
• UDI-Public: (01)00380740160616(17)260430(10)76210UD00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 07P51-21
• Device Lot Number: 76210UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 23 YR
• Patient Sex: Female