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	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone: complete phone number is (b)(6).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 architect prolactin and provided the following data for 1 patient (id: (b)(6) ): on 4 apr 24, the architect prolactin was 50.84 ng/ml.The sample was sent to another laboratory and generated a prolactin result of 20 ng/ml (electrochemiluminescence method).The sample was sent to another laboratory and generated a prolactin result of 13 ng/ml (chemiluminescence method).Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
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 in house testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any non-conformances or deviations with the complaint lot.Ticket search by lot did identify an increase in complaint activity, however trending review did not identify a related trend regarding commonalities for complaint lot number and customer reported issue.In-house testing was conducted with an in-house retained kit of lot 56044ud00.Lot 56044ud00 met specifications, indicating that the product is performing as expected.Labeling was reviewed and was found to address the customer reported issue.Based on the investigation, no systemic issue or deficiency of the architect prolactin lot 56044ud00.
Event or Problem Description
The customer reported falsely elevated architect prolactin and provided the following data for 1 patient (id: (b)(6)): on (b)(6) 2024, the architect prolactin was 50.84 ng/ml.The sample was sent to another laboratory and generated a prolactin result of 20 ng/ml (electrochemiluminescence method).The sample was sent to another laboratory and generated a prolactin result of 13 ng/ml (chemiluminescence method).Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.

• 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: 19280664
• Report Number: 3005094123-2024-00237
• Device Sequence Number: 18040442
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: (01)00380740014865(17)240914(10)56044UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 06/12/2024

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: 09/14/2024
• Device Catalogue Number: 07K76-25
• Device Lot Number: 56044UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2023
• 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 I1000SR INTGR, 01L86-40, (B)(6) ; ARC I1000SR INTGR, 01L86-40, (B)(6)
• Patient Sex: Unknown