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	07/05/2021
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 observing falsely elevated alinity i estradiol results during the peer group test.The customer stated that a sample generated a initial result of 3410.5, with a retest value of 311.69 (target value was 201 with the range being 131-271).It is unknown if mifepristone was being taken in this case.There was no reported impact to patient management.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to add an additional instrument.Section d10- concomitant medical products was updated to reflect this additional instrument.Correction to initial result generated by the customer.It was inadvertently entered as 3410.5 but the result was 341.5.Section b5 was updated to reflect the correct initial result value.Additionally, the units of measure was inadvertently omitted- this information has also been added to section b5.
Event or Problem Description
The customer reported observing falsely elevated alinity i estradiol results during the peer group test.The customer stated that a sample generated a initial result of 341.5 pmol/l with a retest value of 311.69 pmol/l (target value was 201 with the range being 131-271).It is unknown if mifepristone was being taken in this case.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
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12281471
• Report Number: 3005094123-2021-00144
• Device Sequence Number: 12113223
• 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): 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): 12/07/2021

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: 12/01/2021
• Device Model Number: 07P5020
• Device Catalogue Number: 07P50-20
• Device Lot Number: 26282UD00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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: ALINITY I PROC MOD, LN 03R65-01, SN (B)(6) .; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown