MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT PROLACTIN

Catalog Number	07K76-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.There is no further patient information provided by the customer.
Event or Problem Description
The customer reported falsely elevated prolactin results on one patient.The results provided were: (b)(6) 2018: 108.0ng/ml / (b)(6) 2018: 140.0ng/ml.The reference lab testing generated results: 100.61 / 102.71 / and 101.66.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of the complaint trending report determined that there are no trends for the issue for the product.Return testing was not completed as returns were not available.Historical performance in the field of architect prolactin reagent lots using world wide data through abbottlink was evaluated.The median values are within +/-3sd of the mean, indicating that the lots are comparable and performing acceptably in the field.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Peg analysis performed at a reference lab shows a reduction in values compared to the initial results obtained, which indicates a macroprolactin interference.The architect prolactin package insert provides information relating to elevated prolactin results and details around macroprolactin.Based on the investigation no malfunction or product deficiency was identified for the architect prolactin assay.

• Brand Name: ARCHITECT PROLACTIN
• Common Device Name: PROLACTIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 7619375
• Report Number: 3005094123-2018-00020
• Device Sequence Number: 1422663
• Product Code: CFT
• UDI-Device Identifier: 00380740105990
• UDI-Public: 00380740105990
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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 Catalogue Number: 07K76-35
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 09/23/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/26/2018
• 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: ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; ARCHITECT I2000SR ANALYZER, LIST # 03M74-01,; SERIAL # (B)(4); SERIAL # (B)(4)
• Patient Age: 34 YR