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

Model Number	7K76-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final 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 observed a falsely elevated architect prolactin result for a patient.The following data was provided (normal range 3-29 ng/ml): sample id (b)(6), (b)(6) 2023, initial result = 166.14 ng/ml, (b)(6) 2023 result at a different lab = 7.30 ng/ml.Same patient, new sample obtained (b)(6) 2023 and result = 3.16 ng/ml no impact to patient management was reported.
Event or Problem Description
The customer observed a falsely elevated architect prolactin result for a patient.The following data was provided (normal range 3-29 ng/ml): sample id (b)(6) 03may2023 initial result = 166.14 ng/ml, 08may2023 result at a different lab = 7.30 ng/ml.Same patient, new sample obtained 10may2023 and result = 3.16 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section d10 - concomitant product added the complaint investigation for falsely elevated architect prolactin results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations.Labeling was reviewed and found to be adequate and sufficiently addresses the customer¿s issue.The package insert states ¿do not use past expiration date¿.The discrepant result was generated using an expired calibrator.Based on the investigation, no systemic issue or deficiency with the architect prolactin reagent or calibrator was identified, as the device met performance specifications and performed as intended at the customer site.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17021107
• Report Number: 3005094123-2023-00139
• Device Sequence Number: 7555312
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/06/2023

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 Model Number: 7K76-25
• 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): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/06/2023
• 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, ISR53899; ARC I2000SR INST, 03M74-02, ISR53899; ARC PROLACTIN CAL, 07K76-01, 38219UD00
• Patient Sex: Unknown