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

Model Number	07P5020
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section patient identifier = (b)(6).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 falsely elevated alinity estradiol results were observed while performing a proficiency study.The customer stated that sample id (b)(6) generated a result of 492 pmol/l, that had a target value of 336 pmol/l, which is also above the upper limit of 454 pmol/l.No information could be obtained from the customer as to if the samples had mifepristone in them.There was no reported impact to patient management.

• Brand Name: ALINITY I ESTRADIOL REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 12385922
• Report Number: 3005094123-2021-00160
• Device Sequence Number: 14675704
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: 00380740129910
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 04/17/2022
• Device Model Number: 07P5020
• Device Catalogue Number: 07P50-20
• Device Lot Number: 29417UD00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 08/30/2021
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI20590