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	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for patient information, (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There was no further patient information provided by the customer.
Event or Problem Description
The customer observed falsely elevated architect prolactin result one patient.The results provided were: on (b)(6) 2021 sid (b)(6) initial=90.17 ng/ml /repeated at other facility on chemiluminescence methodology=20.40 ng/ml laboratory normal range for women=5.18 to 26.53 ng/ml there was no reported impact to patient management.
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 20320ui00.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.In-house testing was performed with a retained kit of lot 20320ui00, which mimic patient samples, and all specifications were met and found 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.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Per product labeling for diagnostic purposes, results should be used in conjunction with other data; e.G., symptoms, results of other tests, clinical impressions, etc.If the prolactin results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.Based on the investigation no product deficiency was identified for the architect prolactin reagent lot 20320ui00.

• 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: 11967692
• Report Number: 3005094123-2021-00109
• Device Sequence Number: 19937105
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• 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): 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): 06/23/2021

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: 09/02/2021
• Device Model Number: 7K76-25
• Device Catalogue Number: 07K76-25
• Device Lot Number: 20320UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/23/2021
• 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 I1000SR MOD, 01L86-01, (B)(4); ARC I1000SR MOD, 01L86-01, (B)(4)