MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I PROLACTIN REAGENT KIT; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Model Number	07P6620
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
The customer observed a falsely elevated prolactin result for a 21-year-old female when compared to the roche method.The following results were provided: (b)(6) 2023.Sid: (b)(6).Initial result 41.10 ng /ml, sent to biomnis repeated on cobas roche result = 22.2 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section b5.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 or Problem Description
Additional information received from the customer the result with the hbt tube: 41.3 ng/ml no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i prolactin 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 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 issue for the product.Labeling was reviewed and found to be adequate and sufficiently addresses the customer¿s issue.In-house accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot 44167ud00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Device history record review for lot 44167ud00 did not identify any non-conformances or deviations.Based on the investigation, no systemic issue or deficiency with the alinity i prolactin assay for lot 44167ud00 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ALINITY I PROLACTIN REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• 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: 16434660
• Report Number: 3005094123-2023-00053
• Device Sequence Number: 3126905
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: 00380740121570
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 08/31/2023
• Device Model Number: 07P6620
• Device Catalogue Number: 07P66-20
• Device Lot Number: 44167UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 02/24/2023; 04/11/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 03/20/2023; 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2022
• 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, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 21 YR
• Patient Sex: Female