MAUDE Adverse Event Report: A.I.D.D LONGFORD 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	09/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported a falsely depressed alinity i estradiol result for a patient while running on the alinity i processing module.The following data was provided: on (b)(6) 2021 at 9:37am sid (b)(6): initial result: 931.405 pg/ml, repeat results on another alinity analyzer ((b)(6)) at 11:56 am: undiluted result: > 1000 pg/ml, automatic dilution result: > 5000 pg/ml, manual diluted result = 5406 pg/ml.Other laboratory testing: on (b)(6) 2021 at 9:37 am sid (b)(6): lh: 0.487 iu/l, progesterone: 1.461 ng/ml / repeat testing.On same tube at 11:56 am ((b)(6)): lh: 0.46 iu/l, progesterone: 1.64 ng/ml.Additional information received (b)(6) 2021, the customer reran the sample on original analyzer ((b)(6)).The initial result generated >1000 pg/ml and when performed the automatic dilution generated a result of > 5000 pg/ml (raw result: 5017.19 pg/ml).There was no impact to patient management reported.
Event or Problem Description
On (b)(6) 2021, the customer provided a second case: sid: (b)(6).Initial estradiol result = 930 pg/ml which does not correlate with the patient¿s history.The customer reran the sample on another instrument and generated an estradiol result of 1400 pg/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
A1 - patient identifier: sid : (b)(6) and sid: (b)(6) (2 different patient cases).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
On (b)(6) 2021, the customer provided a third case: sid (b)(6) = initial estradiol result = >1000 pg/mg, automatic dilution result = 2397, repeat dilution result = 3896 pg/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6) (sid of third patient case).B5 - describe event or problem: additional patient case received on 22sep2021: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation for falsely depressed alinity i estradiol results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.No elevated complaint activity identified for lot 28049ud00.Trending was reviewed and did not identify any trends for the product for the issue.Accuracy testing was completed using an in-house retained kit of the complaint lot 28049ud00.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing acceptably.Device history record was reviewed and did not identify any non-conformances or deviations.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity i estradiol reagent lot 28049ud00 was identified.G1 all manufacturers: g1 - contact information has been updated to included new contact name, email, address, phone number, and fax number.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 12475651
• Report Number: 3005094123-2021-00174
• Device Sequence Number: 19806098
• Product Code: CHP
• UDI-Device Identifier: 00380740129927
• UDI-Public: 00380740129927
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 02/18/2022

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: 03/19/2022
• Device Model Number: 07P5030
• Device Catalogue Number: 07P50-30
• Device Lot Number: 28049UD00
• 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: 09/08/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 09/22/2021; 02/18/2022
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 09/16/2021; 10/12/2021; 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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
• 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); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01,(B)(6); ALNTY I PROCESSING MODU, (B)(4)
• Patient Sex: Unknown