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

Model Number	7K72-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased architect estradiol results, which questioned by physician on multiple patients.The results provided were: on (b)(6) 2022 sid (b)(6) (b)(6) year old female: initial estradiol aliquot= (b)(6) pg/ml /repeated=(b)(6) pg/ml /repeated after re-spun=(b)(6) pg/ml /repeated original tube= (b)(6) pg/ml on (b)(6) 2022 sid (b)(6) (b)(6) year old female: initial estradiol aliquot = 415 pg/ml/ repeated after re-spun = 6013 pg/ml /repeated original tube= 5926 pg/ml laboratory estradiol reference range: follicular phase: 21-251; mid-cycle phase: 38-649; luteal phase: 21-312; postmenopausal: no hormone replacement therapy: <10-28; hormone replacement therapy: <10-144 there was no reported impact to patient management.
Additional Manufacturer Narrative
Patient identifier = sid= (b)(6) and (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
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 in-house testing for architect estradiol, reagent lot 29368ud00.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.In-house testing was performed with a retained kit of lot 29368ud0, all specifications were met indicating that the lot is performing acceptably.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.As per labelling, for diagnostic purposes, results should be used in conjunction with other data; e.G., symptoms, results of other tests, clinical impressions, etc.If the estradiol results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.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 architect estradiol, reagent lot 29368ud00.

• Brand Name: ARCHITECT 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13760847
• Report Number: 3005094123-2022-00045
• Device Sequence Number: 2481277
• Product Code: CHP
• UDI-Device Identifier: 00380740014711
• UDI-Public: 00380740014711
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 7K72-25
• Device Catalogue Number: 07K72-25
• Device Lot Number: 29368UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR MOD, 01L86-01, (B)(6).; ARC I1000SR MOD, 01L86-01, (B)(6).
• Patient Sex: Unknown