MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin results for a 40-year-old female patient when comparing the patient¿s results when tested at other laboratories.The following results were provided: at the customer¿s site on (b)(6) 2023: prolactin result = 106.9 ng/ml; repeat result = 106.9 ng/ml.On (b)(6) 2023: prolactin result = 106.1 ng/ml.Reference range: female = 5.18-26.53 ng/ml.Cvs lab on (b)(6) 2023: prolactin result = 28.96 ng/ml.Reference range: female = 2.80-29.20 ng/ml; post menopause = 1.80-20.30 ng/ml; pregnant females: 9.70-208.50 ng/ml.Pardini lab on (b)(6) 2023: prolactin result = 11.6 ng/ml; repeat result post dilution = 16.5 ng/ml; repeat result post treatment with peg (prolactin concentration after treatment with polyethylene glycol) = 10.88 ng/ml.Reference range: female = 2.80-29.20 ng/ml; post menopause = 1.80-20.30 ng/ml.A new sample was collected from the patient and tested for prolactin at the customer¿s site.The result was 89.98 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for false elevated alinity i prolactin results included a search for similar complaints, and the review of complaint text, trending data, labeling, in house testing, and device history records.Return testing was not performed as returns were not available.The complaint activity review by lot indicates that the reagent lot performs as expected.A review of tracking and trending did not identify any related trends for the product for the issue.The device history record was reviewed and did not identify any non-conformances or deviations associated with lot 44167ud00 and complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for alinity i prolactin reagent lot 44167ud00.

• Brand Name: ALINITY I PROLACTIN REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16710661
• Report Number: 3005094123-2023-00093
• Device Sequence Number: 1649510
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: 03/22/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 04/20/2023
• 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, AI22701; ALNTY I PROCESSING MODU, 03R65-01, AI22701
• Patient Age: 40 YR
• Patient Sex: Female