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	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely elevated architect prolactin result on a patient born in (b)(6) diagnosed with a pituitary adenoma.Results provided: (b)(6) 2021 = 195.20 ng/ml; another laboratory tested normal; patient typically generates a result around 100 ng/ml (reference range: 5.18-26 ng/ml).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.D8.Was this device service by a third party? no.
Event or Problem Description
The customer reported a falsely elevated architect prolactin result on a menopausal female patient born on (b)(6) 1962 diagnosed with a pituitary adenoma.Results provided: (b)(6) 2021 = 195.20 ng/ml; another laboratory chemiluminescence = 27.1 ng/ml, by ria = 13.9 ng/ml, ria after peg = 19.8 ng/ml; patient typically generates a result around 100 ng/ml (reference range: 5.18-26 ng/ml); additional testing provided: new sample on (b)(6) 2021 = architect prolactin = 42 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false elevated architect prolactin result included a search for similar complaints, and review of complaint text, trending data, labeling, and device history records.In-house accuracy testing of reagent lot 23533ui00 was completed.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review on lot 23533ui00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.In house testing of panels which mimic patient samples was completed using retained samples of the complaint lot.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect prolactin assay, lot number 23533ui00 was identified.

• 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
• MDR Report Key: 11777540
• Report Number: 3005094123-2021-00079
• Device Sequence Number: 14452521
• 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,Followup
• Report Date (Section B): 07/27/2021

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: 12/15/2021
• Device Model Number: 7K76-25
• Device Catalogue Number: 07K76-25
• Device Lot Number: 23533UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/06/2021; 07/27/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/27/2021; 07/27/2021
• 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 I2SR REFURB-SEKAT, 03M74-97, (B)(4); ARC I2SR REFURB-SEKAT, 03M74-97, (B)(4); ARC I2SR REFURB-SEKAT, 03M74-97, (B)(4); ARC I2SR REFURB-SEKAT, 03M74-97, (B)(4)
• Patient Age: 59 YR