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

Model Number	07P5020
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The account questioned the difference in alinity i estradiol results on a patient sample processed on 2 alinity i processing modules.The account does not know which analyzer generated the correct results for sid (b)(6), but the results from serial (b)(4) were reported out of the lab.On (b)(6) 2022 sid (b)(6) (female) generated: alinity i estradiol > 1000.00, 1469.89, 1491.87, 1438.42, 1442.22 pg/ml (serial (b)(4)).Alinity i estradiol 916.48.928.19 pg/ml (serial (b)(4)).Alinity i estradiol <1000, 1473.60, 1424.74, 1430.25 pg/ml (serial (b)(4)).Historical patient values: 125 pg/ml (on (b)(6)2021), 104 pg/ml (on (b)(6)2021), 360 pg/ml (on (b)(6)2021), 120 pg/ml (on (b)(6)2021), 61 pg/ml (on (b)(6)2021), 91 pg/ml (on (b)(6)2021).No other specific patient information is available.No impact to patient management was reported.
Additional Manufacturer Narrative
Patient identifier does not contain enough spaces, the entire id is (b)(6).Contact phone, the entire phone is (b)(6).An evaluation is in process.A followup report will be provided when the evaluation is complete.
Additional Manufacturer Narrative
Section b.5 updated information: alinity i estradiol <1000 (serial (b)(6)) to alinity i estradiol >1000 (serial (b)(6)).An evaluation is in process.A followup report will be provided when the evaluation is complete.Section b.5 updated information: alinity i estradiol <1000 (serial (b)(6)) to alinity i estradiol >1000 (serial (b)(6)).
Event or Problem Description
Updated information: alinity i estradiol >1000 (serial (b)(6)).
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A complaint trending review determined that there is no adverse trend for the product for the complaint issue.No elevated complaint activity was identified for lot 32197ud00.No adverse trends were identified.Labeling review determined that there is sufficient labeling to aid the customer in troubleshooting this issue.A review of the product quality history for the lot number 32197ud00 using search of the corrective and preventive actions system did not identify issues associated with the customer observation.Accuracy testing was performed using the complaint lot.All validity and acceptance criteria were met, demonstrating that the lot is performing acceptably.No product deficiency was identified.

• 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 N39 E-932 ; 433331157
• MDR Report Key: 13389181
• Report Number: 3005094123-2022-00022
• Device Sequence Number: 4678285
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: 00380740129910
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 05/10/2022

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: 07/06/2022
• Device Model Number: 07P5020
• Device Catalogue Number: 07P50-20
• Device Lot Number: 32197UD00
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 02/01/2022; 04/14/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/02/2022; 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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, AI20506, AI20839; ALNTY I PROCESSING MODU 03R65-01, AI20506, AI20839; ALNTY I PROCESSING MODU 03R65-01, AI20506, AI20839
• Patient Sex: Female