MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT PROLACTIN REAGENT KIT; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number	07K76-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect prolactin results which questioned by the physician on multiple patients.The customer sent out multiple times specimens at quest diagnostic laboratory for repeat on prolactin and monomeric prolactin which are normal according to quest reference range.The result provided were: patient 1 81yrs old male: on (b)(6) 2022 at quest total prolactin=11.2 ng/ml; monomeric prolactin=5.2 ng/ml.(b)(6) 2019 architect prolactin result= 42.05 ng/ml /sent sample to quest results: total prolactin= 12.4 ng/ml; monomeric prolactin= 4.0 ng/ml; previous history: (b)(6) 2018 architect prolactin result= 71.71 ng/ml /sent sample to quest results: total prolactin= 16.4 ng/ml; monomeric prolactin= 4.6ng/ml.On (b)(6) 2015=57.04 ng/ml, on (b)(6) 2015=93.82 ng/ml, on (b)(6) 2015=29.19 ng/ml, on (b)(6) 2015= 43.92 ng/ml, on (b)(6) 2015=7.36 ng/ml, on (b)(6) 2016=12.82, on (b)(6) 2016=62.82 ng/ml, on (b)(6) 2016=5.59 ng/ml, on (b)(6) 2017= 4.62 ng/ml, on (b)(6) 2017=7.77 ng/ml, on (b)(6) 2018=28.43 ng/ml, (b)(6) 2018 =25.89 ng/ml, (b)(6) 2018=71.71 ng/ml, on (b)(6) 2018 at quest.Total prolactin= 16.4 ng/ml; prolactin,monomeric=4.6 ng/ml.Patient 2: 64yrs old male: architect prolactin result on (b)(6) 2023 architect prolactin result= 23.0 ng/ml /sent sample to quest results: total prolactin= 15.4 ng/ml; monomeric prolactin= 9.0 ng/ml, on (b)(6) 2023= 24.4 ng/ml.Sent sample to quest.Results: total prolactin= 11.2; monomeric prolactin= 5.2ng/ml.Previous history: on (b)(6) 2022=20.2 h ng/ml laboratory reference range for abbott prolactin= male; 3-19 ng/ml; quest total prolactin=2.0 to 18 ng/ml; monomeric prolactin=3.4 to 14.8 ng/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
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 architect prolactin results which questioned by the physician on multiple patients.The customer sent out multiple times specimens at quest diagnostic laboratory for repeat on prolactin and monomeric prolactin which are normal according to quest reference range.The result provided were: patient 1 81yrs old male: on 02aug2022 at quest total prolactin=11.2 ng/ml; monomeric prolactin=5.2 ng/ml 20aug2019 architect prolactin result= 42.05 ng/ml /sent sample to quest results: total prolactin= 12.4 ng/ml; monomeric prolactin= 4.0 ng/ml; previous history: 21aug2018 architect prolactin result= 71.71 ng/ml /sent sample to quest results: total prolactin= 16.4 ng/ml; monomeric prolactin= 4.6ng/ml /on 12feb2015=57.04 ng/ml/on 30jun2015=93.82 ng/ml /on 17sep2015=29.19 ng/ml /on 28oct2015= 43.92 ng/ml /on 04dec2015=7.36 ng/ml /on 08jun2016=12.82 /on 02sep2016=62.82 ng/ml /on 10nov2016=5.59 ng/ml / on 22may2017= 4.62 ng/ml /on 28nov2017=7.77 ng/ml /on 09may2018=28.43 ng/ml /30may2018=25.89 ng/ml /21aug2018=71.71 ng/ml /on 18sep2018 at quest total prolactin= 16.4 ng/ml; prolactin,monomeric=4.6 ng/ml patient 2: 64yrs old male: architect prolactin result on 07jul2023 architect prolactin result= 23.0 ng/ml /sent sample to quest results: total prolactin= 15.4 ng/ml; monomeric prolactin= 9.0 ng/ml /on 16mar2023= 24.4 ng/ml /sent sample to quest results: total prolactin= 11.2; monomeric prolactin= 5.2ng/ml /previous history: on 02dec2022=20.2 h ng/ml laboratory reference range for abbott prolactin= male; 3-19 ng/ml; quest total prolactin=2.0 to 18 ng/ml; monomeric prolactin=3.4 to 14.8 ng/ml there was no reported impact to patient management.
Additional Manufacturer Narrative
Updated section d4 expiration date: to 9/26/2023 from 8/26/2023.The complaint evaluation 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 for architect prolactin reagent lot number 45111ud00.The ticket trending review of at least 12 months complaint data for the likely cause list number does not identify any non-statistical trend.The trending report review determined that there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.In-house testing meets acceptance criteria, and the product is performing as expected.Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Such specimens may show either falsely elevated or depressed values when tested with assay kits such as architect prolactin that employ mouse monoclonal antibodies.Additional information may be required for diagnosis.Prolactin may exist in alternate structural forms (e.G., macroprolactin) which may exhibit variable levels of physiological activity.In patients with elevated prolactin results, additional information may be required for diagnosis.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect prolactin reagent lot number 45111ud00.Updated information in section g1: contact office address 1, contact office city, contact office postal code, contact office country, contact office first and last name, contact office email, contact office phone number, contact office fax number.

• Brand Name: ARCHITECT 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17589650
• Report Number: 3005094123-2023-00223
• Device Sequence Number: 6392064
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: 09/26/2023
• Device Catalogue Number: 07K76-25
• Device Lot Number: 45111UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)
• Patient Sex: Male