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

Model Number	07P6630
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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 stated that falsely elevated alinity i prolactin results were generated for two patient samples.The elevated values did not match the clinical history.Testing of the samples at different laboratories generated lower values using alternate methods.The following data was provided.Patient 1 sid (b)(4): drawn on (b)(6) 2021.Alinity 44.72 and siemens 9.80 ng/ml sid (b)(4): drawn again on (b)(6) 2021.Alinity 43.49, siemens 11.0, dxl 17.79 and roche 17.0 ng/ml patient 2 sid (b)(4): drawn on (b)(6) 2021.Alinity 74.52 and siemens 14.5 ng/ml sid(b)(4): drawn again on(b)(6) 2021.Alinity 60.82, siemens 11.0, dxl 17.63 and roche 20.0 ng/ml.No adverse impact to patient management was reported.
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 inhouse testing of retained kits with the complaint lot number.Trending review determined no adverse trend for the issue for the product.Historical complaint review determined there is normal complaint activity for lot number.Device history record review did not identify any non-conformances or deviations for the likely cause lot and complaint issue.Inhouse testing of a retained kit suggested that the performance of the lot is as expected.Based on the investigation, no systemic issue or deficiency with the alinity i prolactin reagent lot 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12872321
• Report Number: 3005094123-2021-00227
• Device Sequence Number: 12268291
• Product Code: CFT
• UDI-Device Identifier: 00380740121587
• UDI-Public: 00380740121587
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 01/04/2022
• Device Model Number: 07P6630
• Device Catalogue Number: 07P66-30
• Device Lot Number: 24102UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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 Sex: Unknown