MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	07P5131
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false positive alinity i total -hcg result for one sample.The following data was provided: on (b)(6) 2023, sid: (b)(6) initial result = 43.26 iu/l (positive) which was questioned by the physician the sample was repeated with a 1:15 dilution and generated a result of 7000 iu/l a new sample was drawn (sid: (b)(6) and generated a negative result.The original sample was repeated on another alinity and generated a negative result of 2.42 iu/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i total ss-hcg results 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 testing of retained reagent kit of the complaint lot number.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review for lot 42496ud00 did not identify any non-conformances or deviations with the complaint lot.In-house accuracy testing of a retained reagent kit of lot 42496ud00 was performed.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the alinity i total ss-hcg for lot number 42496ud00 was identified.

• Brand Name: ALINITY I TOTAL B-HCG REAGENT KIT
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; 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: 16499117
• Report Number: 3005094123-2023-00064
• Device Sequence Number: 12357836
• Product Code: DHA
• UDI-Device Identifier: 00380740160623
• UDI-Public: 00380740160623
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/12/2023

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: 07/22/2023
• Device Model Number: 07P5131
• Device Catalogue Number: 07P51-31
• Device Lot Number: 42496UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2022
• 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, AI21687; ALNTY I PROCESSING MODU, 03R65-01, AI21687
• Patient Sex: Unknown