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

Catalog Number	07P50-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely depressed alinity i estradiol result for a patient on the alinity i processing module.The sample was repeated after the physician questioned the result.The following data was provided for sid (b)(6).Initial result =414.5 pg/ml (1522 pmol/l) and the repeat result = 4087.8 pg/ml (15008 pmol/l).The customer uses a reportable range: follicular: 77-921.Mid-cycle:140-2380.Luteal:77-1145.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely depressed alinity i estradiol result for a patient on the alinity i processing module.The sample was repeated after the physician questioned the result.The following data was provided for sid (b)(6).Initial result =414.5 pg/ml (1522 pmol/l) and the repeat result = 4087.8 pg/ml (15008 pmol/l).The customer uses a reportable range: follicular: 77-921 mid-cycle:140-2380 luteal:77-1145 there was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased alinity i estradiol results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Trending review determined no related trend for the issue for the product.Device history record review did not identify any related non-conformances or deviations with the likely cause lot and complaint issue.The overall performance of alinity i estradiol reagents in the field was reviewed using data gathered through abbottlink from customers worldwide.The median population result for the complaint lot(s) are within established limits, indicating that the lot(s) are performing acceptably in the field.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information no systemic issue or deficiency of alinity i estradiol, lot number 50032ud00, was identified.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17789091
• Report Number: 3005094123-2023-00254
• Device Sequence Number: 20446663
• Product Code: CHP
• UDI-Device Identifier: 00380740129927
• UDI-Public: 00380740129927
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/11/2023

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: 12/06/2023
• Device Catalogue Number: 07P50-30
• Device Lot Number: 50032UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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 MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown