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

Catalog Number	07P51-31
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive alinity i total b-hcg result for an 18-year-old female.The doctor questioned the positive result.The original sample was repeated and was negative.The patient was recollected, and the second sample was also negative.The following data was provided: original sample sid (b)(6): initial result = 103.8 miu/ml.Sid (b)(6) (same patient/same sample): repeat result = < 2.42 miu/ml.Second sample collected: sid (b)(6): initial result = < 2.42 miu/ml.Normal range: <5 miu/ml = negative, 5 - 25 miu/ml = indeterminate (grayzone), >25 miu/ml = positive.All levels of qc were within range.Customer verified there was no fibrin in the serum sample.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.A1 - patient identifier: (b)(6), (same sample/same patient); (b)(6) (second sample collected on same patient).All available patient information was included.Additional patient details are not available.
Additional 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 was completed.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.Review of tracking and trending for the alinity i total b-hcg assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 65726ud00.Additionally, accuracy testing was completed with a retained kit of the complaint lot.All validity and acceptance criteria were met, indicating the lot is performing as expected.A review of the device history record did not identify any nonconformances or deviations associated with the complaint lot and the complaint issue.Labeling was reviewed and adequately addresses the current issue.Based on the investigation, no systemic issue or product deficiency of the alinity i total b-hcg reagent lot 65726ud00 was identified.
Event or Problem Description
The customer reported a false positive alinity i total b-hcg result for an 18-year-old female.The doctor questioned the positive result.The original sample was repeated and was negative.The patient was recollected, and the second sample was also negative.The following data was provided: original sample sid (b)(6): initial result = 103.8 miu/ml.Sid (b)(6) (same patient/same sample): repeat result = < 2.42 miu/ml.Second sample collected: sid (b)(6): initial result = < 2.42 miu/ml.Normal range: <5 miu/ml = negative.5 - 25 miu/ml = indeterminate (grayzone).>25 miu/ml = positive.All levels of qc were within range.Customer verified there was no fibrin in the serum sample.There was no impact to patient management 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: 21855801
• Report Number: 3005094123-2025-00170
• Device Sequence Number: 17323216
• Product Code: DHA
• UDI-Device Identifier: 00380740160623
• UDI-Public: (01)00380740160623(17)250624(10)65726UD00
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/29/2025

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: 06/24/2025
• Device Catalogue Number: 07P51-31
• Device Lot Number: 65726UD00
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: 18 YR
• Patient Sex: Female