MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I ESTRADIOL

Catalog Number	07P50-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that a falsely decreased alinity i estradiol result of 897 pg/ml was generated for a patient sample that retested at 7112 pg/ml.The initial low result did not match the patient's clinical history and was questioned which prompted the retesting of the sample.No adverse impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined there is normal complaint activity for the likely cause lot, 95187ui00.Tracking and trending review did not identify any trends for the complaint issue for the alinity i estradiol reagent.A review of labeling was performed and adequately addresses the customer issue.In the labelling it states that samples with an estradiol value exceeding 1000 pg/ml (3670 pmol/l) are flagged with the code "> 1000 pg/ml"(> 3670 pmol/l) and may be diluted with either the automated dilution protocol or the manual dilution procedure.Dilutions performed using the manual dilution protocol should only use the alinity i estradiol manual diluent.It is recommended to use 1:10 dilution.Use of incorrect diluent may result in under or over recovery of samples.Based on the information within the complaint record, no systemic issue or product deficiency was identified for the alinity i estradiol reagent.

• Brand Name: ALINITY I ESTRADIOL
• Common Device Name: ESTRADIOL
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 8869882
• Report Number: 3005094123-2019-00217
• Device Sequence Number: 11522849
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: 00380740129910
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (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): 10/11/2019

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: 07/26/2019
• Device Catalogue Number: 07P50-20
• Device Lot Number: 95181UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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: ALINITY I PROCESSING MODULE, LN 03R65-01; SN (B)(4)