MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT ESTRADIOL REAGENT KIT; RADIOIMMUNOASSAY, ESTRADIOL

Model Number	7K72-35
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a falsely elevated architect estradiol result for a patient having an intrauterine device removed.The patient was not pregnant and had a progesterone result of 0.32.The patient's sample generated an estradiol result of 3670 pmol/l on the architect.The physician expected the estradiol result to be a low value.The sample was retested on roche and generated 15 pg/ml.There was no reported impact to patient management.
Additional Manufacturer Narrative
All available patient information was included.No additional information was provided.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.
Additional Manufacturer Narrative
This follow up submission is being submitted to reflect the current contact information in section g1.This follow up submission is also being submitted to correct the product/lot information as it was inadvertently omitted from the initial submission.The following sections were updated to reflect the corrected information.Section d4: catalogue no updated from 07k72-35 to 07k72-74.Lot no updated from unknown to 29368ud01.Expiration date from blank to 7/16/2021.Section h4: device mfg date: u[dated from blank to 4/17/2022.

• Brand Name: ARCHITECT ESTRADIOL REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 12819566
• Report Number: 3005094123-2021-00211
• Device Sequence Number: 14887239
• Product Code: CHP
• UDI-Device Identifier: 00380740106065
• UDI-Public: 00380740106065
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 07/16/2021
• Device Model Number: 7K72-35
• Device Catalogue Number: 07K72-74
• Device Lot Number: 29368UD01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR54545.; ARC I2000SR INST, 03M74-02, ISR54545.
• Patient Sex: Female