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

Catalog Number	07K72-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An in-house investigation confirmed that the drug mifepristone causes interference/cross-reactivity with the architect estradiol assay leading to falsely elevated estradiol results.A product correction letter was issued on 05feb2019 to all architect estradiol and alinity i estradiol customers who received one of the impacted lots.The product correction letter informs the customer that patients undergoing mifepristone therapy should not be tested with the architect estradiol or the alinity i estradiol assays for up to two weeks post their last dose.It also instructs the customer to review the letter with their medical director.The architect and alinity estradiol package inserts will be updated to include new information regarding interference/cross-reactivity between the architect and alinity estradiol assays and the drug mifepristone.
Event or Problem Description
The customer reported a falsely elevated architect estradiol result on one patient.The results provided were: initial = >5000 pg/ml with a 1:5 dilution / the sample was sent out for confirmation on a roche method = 65 pg/ml.A new sample was collected and generated >5000 pg/ml on the architect.The customer further indicated sid (b)(4) on (b)(6)2019 = 1641 pg/ml for estradiol; testosterone = 114 ng/ml (normal range for this patient 8-48ng/dl); and free testosterone = 24.2 ng/ml.The patient is on miferistone and the customer is inquiring about drug interference.There was no impact to patient management reported.

• Brand Name: ARCHITECT ESTRADIOL
• Common Device Name: ESTRADIOL
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 9167641
• Report Number: 3005094123-2019-00282
• Device Sequence Number: 2774430
• Product Code: CHP
• UDI-Device Identifier: 00380740014711
• UDI-Public: 00380740014711
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/23/2019
• Device Catalogue Number: 07K72-25
• Device Lot Number: 02097UI00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005094123-02/8/19-001-C
• Patient Sequence Number: 1