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

Catalog Number	07K76-35
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely depressed architect prolactin result for a 48 year old female patient.The following data was provided (customer provided normal range: 5.18 to 26.0 ng/ml): (b)(6) 2023, sid (b)(6), initial result (lot 48500ud00) = 74.86 ng/ml.(b)(6) 2023, sid (b)(6), initial result (lot 51258ed00) = 15.68 ng/ml.The customer is questioning the new sample that was collected on (b)(6) 2023.The patient has a history of a pituitary tumor and previous prolactin results were in the range of 50 to 70 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Completed information for section a1 patient identifier: sid (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 observed a falsely depressed architect prolactin result for a 48 year old female patient.The following data was provided (customer provided normal range: 5.18 to 26.0 ng/ml): 04sep2023 sid (b)(6) initial result (lot 48500ud00) = 74.86 ng/ml.25sep2023 sid (b)(6) initial result (lot 51258ed00) = 15.68 ng/ml.The customer is questioning the new sample that was collected on (b)(6) 2023.The patient has a history of a pituitary tumor and previous prolactin results were in the range of 50 to 70 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed architect prolactin results 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.A review of customer data aligned with the customer¿s issue and no additional issues were identified.A search for similar complaints indicates that reagent lot 51258ud00 performs as expected.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 with lot number 51258ud00 and the complaint issue.In-house accuracy testing was completed using panels which mimic patient samples using an in-house retained kit with complaint lot number 51258ud00.All specifications were met indicating that lot 51258ud00 is performing acceptably.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the architect prolactin reagent lot number 51258ud00 was identified.

• 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: 17987528
• Report Number: 3005094123-2023-00283
• Device Sequence Number: 7221781
• Product Code: CFT
• UDI-Device Identifier: 00380740105990
• UDI-Public: 00380740105990
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/04/2023

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: 04/11/2024
• Device Catalogue Number: 07K76-35
• Device Lot Number: 51258UD00
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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 I2000SR INST, 03M74-02, ISR62442; ARC I2000SR INST, 03M74-02, ISR62442
• Patient Age: 48 YR
• Patient Sex: Female