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

Catalog Number	07P66-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
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 one 23-year-old female patient.The following data was provided: (b)(6) 2023: prolactin tested with the customer using an architect at (b)(6) with a result of 18.25 ng/ml (normal).On (b)(6) 2023, she returned to do all her hormonal tests again and this time the prolactin was processed for sid (b)(6) on the alinity at (b)(6) with a result of 78.26 ng/ml (elevated).This sample was repeated and generated a result of 73.79 ng/ml (elevated).The patient follows up with her doctor and he recommends going to another laboratory and obtained a normal result.The patient goes 3 days later to yet another lab to have a third sample tested and the result obtained is normal.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i prolactin results included a review of data and information provided by the customer, ticket trending review, device history record review, and labeling review.Additionally, in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 52220ud00 and complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.In addition, accuracy testing was completed using panels which mimic patient samples with an in-house retained reagent kit of lot 52220ud00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Based on this investigation, no systemic issue or deficiency with the alinity i prolactin reagent, lot number 52220ud00 was identified.Section d4 - expiration date: updated from blank to 10may2024.Section h4 - device mfg date: updated from blank to 15jun2023.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin results for one 23-year-old female patient.The following data was provided: (b)(6) 2023: prolactin tested with the customer using an architect at (b)(6) with a result of 18.25 ng/ml (normal).On (b)(6) 2023, she returned to do all her hormonal tests again and this time the prolactin was processed for sid (b)(6) on the alinity at (b)(6) with a result of 78.26 ng/ml (elevated).This sample was repeated and generated a result of 73.79 ng/ml (elevated).The patient follows up with her doctor and he recommends going to another laboratory and obtained a normal result.The patient goes 3 days later to yet another lab to have a third sample tested and the result obtained is normal.There was no impact to patient management reported.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18428444
• Report Number: 3005094123-2024-00004
• Device Sequence Number: 12695449
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: 00380740121570
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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: 05/10/2024
• Device Catalogue Number: 07P66-20
• Device Lot Number: 52220UD00
• 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: 02/26/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 23 YR
• Patient Sex: Female