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	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: sample id's are (b)(6).All available patient information was included.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: customer reference range is > 20 ng/ml.On (b)(6) 2023 sample id: 2312071010 generated a result of 141 ng/ml on (b)(6) 2023 sample id: 2310131045 generated a result of 176 ng/ml.It was reported that the patient was retested at another laboratory, which generated a result less than 20 patient normal according to the endocrinologist and there was nothing to report on the mri.It was reported that the patient had the mri due to the prolactin results.It is unknown if the patient had iv contrast for the mri.The customer confirmed that there was no reported patient harm and 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 specimens 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 nonconformances, or deviations associated with the complaint lots and customer reported issue.Ticket search by lot identified lot 56044ud00did not have an increase in complaint activity.The review of ticket and trending concluded that there were no identified trends.In-house testing was conducted using an in-house retained assay kit, which concluded all specifications were met, indicating that the lot is performing as expected.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the architect prolactin, lot 56044ud00.Section b5 contains a correction to the customer reference range.
Event or Problem Description
The customer reported falsely elevated architect prolactin and provided the following data for 1 patient: customer reference range is > 20 ng/ml.On (b)(6) 2023 sample id: (b)(6) generated a result of 141 ng/ml.On (b)(6) 2023 sample id: (b)(6) generated a result of 176 ng/ml.It was reported that the patient was retested at another laboratory, which generated a result less than 20.Patient normal according to the endocrinologist and there was nothing to report on the mri.It was reported that the patient had the mri due to the prolactin results.It is unknown if the patient had iv contrast for the mri.The customer confirmed that there was no reported patient harm and there was no reported impact to patient management.Correction: customer reference range is < 20 ng/ml, not > 20 ng/ml.

• 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: 18407483
• Report Number: 3005094123-2023-00386
• Device Sequence Number: 8710936
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/15/2024

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: 12/18/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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