MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ARCHITECT PROLACTIN

Model Number	7K76-35
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2020
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 was no additional patient information provided by the customer.
Event or Problem Description
The customer reported falsely elevated architect prolactin results for 10 patients in comparison to a siemens method.The results provided were only for 9 patients: on 30mar2020 abbott results = 35.9ng/ml (reference range 3.3-26.7ng/ml), siemens results = 26.4ng/ml (reference range 2.8-29.2ng/ml).On (b)(6) 2020 the customer retested 11 patients and 8 of the eleven had a shift between architect and siemens of >25%: pt#1 arch = 38.02 / siemens = 29.32; pt#2 118.58 / 94.30; pt#4 arch = 38.29 / siemens = 27.50; pt#5 arch = 42.09 / siemens=28.30; pt#6 45.49 / 34.40; pt#8 arch = 34.81 / siemens = 25.90; pt#9 57.78 / 32.60; pt#11 arch =34.68 / 22.48ng/ml.There was no reported impact to patient management.
Additional Manufacturer Narrative
No issues with the reaction curve were identified and controls tested on the same day using the same reagent bottle met package insert specifications.No issues with sample condition or instrument cleaning were indicated and review of calibration data further indicated no anomalies.No customer returns were available for evalulation.The ticket searches determined normal complaint activity for the complaint lot.This is the only complaint received to date for this lot.The complaint trending report review determined that there is no adverse trend for the issue for the product.Customer field data was used to assess the performance of the architect anti-hbs assay using world wide data.The median population result for the lot is comparable with all other lots in the field and confirms no systemic issue for the lot.A review of the product quality history for the lot number using search of the corrective and preventive actions did not identify issues associated with the customer observation.Labeling was reviewed which adequately addresses the current issue.No product deficiency was identified.

• Brand Name: ARCHITECT PROLACTIN
• Common Device Name: PROLACTIN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9977516
• Report Number: 3005094123-2020-00090
• Device Sequence Number: 2952714
• Product Code: CFT
• UDI-Device Identifier: 00380740105990
• UDI-Public: 00380740105990
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (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): 05/13/2020

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: 07/30/2020
• Device Model Number: 7K76-35
• Device Catalogue Number: 07K76-35
• Device Lot Number: 07218UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2000
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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, LN 03M74-02,; ARCHITECT I2000SR ANALYZER,LN 03M74-02,; SERIAL # (B)(4); SERIAL # (B)(4)