MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I ESTRADIOL REAGENT KIT; RADIOIMMUNOASSAY, ESTRADIOL

Model Number	07P5030
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
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.Patient identifier sids: (b)(6).
Event or Problem Description
The customer reported a falsely decreased alinity i estradiol result on a female patient.Results provided: (b)(6) 2023, (b)(6) = 3017 / 3243 pg/ml (alinity serial number (b)(6 ) (b)(6) 2023 (b)(6)= 565 pg/ml (alinity serial number (b)(6) ) repeated both samples on (b)(6) 2023: (b)(6) = 3672 pg/ml; (b)(6)= >1000 / 3415 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity for lot 45365ud00 did not identify an increase.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Customer field data was used to assess the performance of the alinity i estradiol assay using worldwide data through abbottlink.Review shows that the median patient results for lot 45365ud00 is comparable with other lots in the field confirming no systemic issue for the lot.A review of product labeling was performed which provides appropriate information related to the customer¿s issue.Based on the available information, no deficiency of the alinity i estradiol assay was identified.
Event or Problem Description
The customer reported a falsely decreased alinity i estradiol result on a female patient.Results provided: 03apr2023 sid (b)(6) = 3017 / 3243 pg/ml (alinity serial number ai04846).04apr2023 sid (b)(6) = 565 pg/ml (alinity serial number ai04845).Repeated both samples on 05apr2023: sid (b)(6) = 3672 pg/ml; sid (b)(6) = >1000 / 3415 pg/ml no impact to patient management was reported.

• Brand Name: ALINITY I ESTRADIOL REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 16794867
• Report Number: 3005094123-2023-00108
• Device Sequence Number: 6386659
• Product Code: CHP
• UDI-Device Identifier: 00380740129927
• UDI-Public: 00380740129927
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 07/29/2023
• Device Model Number: 07P5030
• Device Catalogue Number: 07P50-30
• Device Lot Number: 45365UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MOD, 03R65-01, (B)(6) ; ALNTY I PROCESSING MOD, 03R65-01,(B)(6)
• Patient Sex: Female