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	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased alinity i estradiol results which questioned by the physician on multiple patients from multiple specimens.The results provided were: on (b)(6) 2024, patient 1 sid (b)(6) pmol/l /repeated= 11705.3 pmol/l; second specimen sid(b)(6)=1872.3 pmol/l ; third specimen sid (b)(6)=13230.6 pmol/l.Patient 4: sid (b)(6) ,initial= 2259.9 pmol/l /repeated on (b)(6) 2024=4361.6 pmol/l on (b)(6) 2024 patient 2 sid (b)(6) , initial= 4296 pmol/l /repeated=4779.5 pmol/l; second specimen on (b)(6) 2024 sid (b)(6), initial=2773.1 pmol/l /repeated=8476.2 pmol/l.On (b)(6) 2024 patient 3: sid (b)(6) , initial=6117.8 pmol/l /repeated on (b)(6) 2024=5476.4 and 6625.4 pmol/l; second specimen on (b)(6) 2024 sid (b)(6) initial=734.5 pmol/l /repeated=1077.5 pmol/l and 11930.5 pmol/l there was no reported impact to patient management.
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased alinity i estradiol results which questioned by the physician on multiple patients from multiple specimens.The results provided were: on (b)(6) 2024 patient 1 sid (b)(6)=9596.4 pmol/l /repeated= 11705.3 pmol/l; second specimen sid (b)(6)=1872.3 pmol/l ; third specimen sid (b)(6)=13230.6 pmol/l patient 4: sid (b)(6) initial= 2259.9 pmol/l /repeated on (b)(6) 2024=4361.6 pmol/l on (b)(6) 2024 patient 2 sid (b)(6) initial= 4296 pmol/l /repeated=4779.5 pmol/l; second specimen on (b)(6) 2024 sid (b)(6) initial=2773.1 pmol/l /repeated=8476.2 pmol/l on (b)(6) 2024 patient 3: sid (b)(6) initial=6117.8 pmol/l /repeated on (b)(6) 2024=5476.4 and 6625.4 pmol/l; second specimen on (b)(6) 2024 sid (b)(6) initial=734.5 pmol/l /repeated=1077.5 pmol/l and 11930.5 pmol/l there was no reported impact to patient management.
Additional Manufacturer Narrative
Updated information in section d4 primary udi number.The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and field data for alinity i estradiol reagent lot: 54137ud00.The ticket search determined that there is as expected complaint activity for the likely cause lot 54137ud00.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.Historical performance of the alinity i estradiol reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The median patient results for the lots for nonreactive results are comparable with other lots in the field confirming no systemic issue for the lots.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the labeling addresses the customer¿s issue.A manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on the investigation no product deficiency was identified for the alinity i estradiol reagent lot: 54137ud00.

• 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: 18874348
• Report Number: 3005094123-2024-00104
• Device Sequence Number: 20813147
• Product Code: CHP
• UDI-Device Identifier: 00380740129927
• UDI-Public: (01)00380740129927(17)240413(10)54137UD00
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: 04/13/2024
• Device Catalogue Number: 07P50-30
• Device Lot Number: 54137UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2023
• 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
• Usage of Device: Unknown
• 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