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	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: patient 1, patient 2, patient 3, patient 4, patient 5, patient 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 falsely elevated alinity i prolactin results for 6 patients.The customer also noticed a shift up in both levels of controls.The samples were tested on a different method which generated lower results.The following data was provided: patient 1: sample collection date: (b)(6) 2022, alinity result = 52.44 ng/ml, chemiluminescence method result = 36.2 ng/ml, chemiluminescence reference values: women: pre-menopause = 2.8 to 29.2 ng/ml, post-menopause = 1.8 to 20.3 ng/ml; men = 2.1 to 17.7 ng/ml.Patient 2: alinity results performed on (b)(6) 2022 = 80.11 ng/ml, 81.50 ng/ml, result from hermes pardini (hp) = 21.0 ng/ml.Patient 3: alinity results performed on (b)(6) 2022 = 31.27 ng/ml, 30.56 ng/ml, result from hermes pardini (hp) = 9.3 ng/ml.Patient 4: sample collection date: (b)(6) 2022, alinity result = 15.41 ng/ml, chemiluminescence method result = 9.7 ng/ml, chemiluminescence reference values: women: pre-menopause = 2.8 to 29.2 ng/ml, post-menopause = 1.8 to 20.3 ng/ml; men = 2.1 to 17.7 ng/ml.Patient 5: sample collection date: (b)(6) 2022, alinity result = 35.06 ng/ml, chemiluminescence method result = 25.7 ng/ml, chemiluminescence reference values: women: pre-menopause = 2.8 to 29.2 ng/ml, post-menopause = 1.8 to 20.3 ng/ml; men = 2.1 to 17.7 ng/ml.Patient 6: sample collection date: (b)(6) 2022, alinity result performed on 18nov2022 = 97.55 ng/ml, alinity result performed on 21nov2022 = 108.71 ng/ml, chemiluminescence method result = 10.1 ng/ml, chemiluminescence reference values: women: pre-menopause = 2.8 to 29.2 ng/ml, post-menopause = 1.8 to 20.3 ng/ml; men = 2.1 to 17.7 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, device history record review, and labeling review.In-house testing of retained reagent kit was also 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.Ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lot number 40168ud00 and complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.Accuracy testing was completed using panels which mimic patient samples with an in-house retained reagent kit of lot 40168ud00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Based on this investigation, no systemic issue or deficiency with the alinity i prolactin reagent, lot number 40168ud00 was identified.

• 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: 16003811
• Report Number: 3005094123-2022-00296
• Device Sequence Number: 12444651
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: 00380740121570
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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: 04/19/2023
• Device Model Number: 07P6620
• Device Catalogue Number: 07P66-20
• Device Lot Number: 40168UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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, AI01623; ALNTY I PROCESSING MODU, 03R65-01, AI01623
• Patient Sex: Unknown