MAUDE Adverse Event Report: A.I.D.D LONGFORD 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	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect prolactin results which questioned by the physician for multiple patients.The one result example provided were: sid (b)(6) (female, 43 years old): on (b)(6) 2022 initial= 71.48 ng/ml (laboratory reference range for prolactin= 1 to 25 ng/ml) /sent specimen to quest laboratory =14 (reference range 3 to 30) and monomeric prolactin=4.8 (reference range 3.2 to 25.2) /redrawn the patient on (b)(6) 2022 sent to quest=18.4 /on monomeric=5.2 the specimen tested for hama: <6 ng/ml and heterophile ab: negative.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint evaluation 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 for architect prolactin reagent lot 34434ud00.The ticket search by lot indicates that the reagent lot performs as expected for this product.Trending review determined no trend for the issue for the product.Return testing was not completed as returns were not available.The ticket trending review of at least 12 months complaint data for the likely cause list number does not identify any non-statistical trend.Accuracy testing was performed using a retained kit with panels, which mimic patient samples, and all specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect prolactin reagent lot 34434ud00.

• Brand Name: ARCHITECT PROLACTIN REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; 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: 15758983
• Report Number: 3005094123-2022-00247
• Device Sequence Number: 6227093
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 12/06/2022
• Device Model Number: 7K76-25
• Device Catalogue Number: 07K76-25
• Device Lot Number: 34434UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR54171; ARC I2000SR INSTRUMENT(2007), 03M74-02, ISR54171
• Patient Age: 43 YR
• Patient Sex: Female