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

Catalog Number	07P50-20
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
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 observed imprecise results while using alinity i estradiol reagents.The following data was provided.Automatic dilution 1:5 1688, 1592 pg/ml.Repeat (manual dilution 1:5 using calibrator a material) 2720 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, labeling review, and field data review.The product was not returned.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.Labeling was reviewed and found to be adequate.Abbott link world wide data was used to evaluate historical product field performance.Patient data was analyzed, and evaluation indicated that the patient median result for the complaint lot was comparable to other lots in the field between june 2018 and december 2018.No unusual reagent lot performance was identified.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified, and no product deficiency was found.

• 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: 8007519
• Report Number: 3005094123-2018-00073
• Device Sequence Number: 221615
• Product Code: CHP
• UDI-Device Identifier: 00380740129910
• UDI-Public: 00380740129910
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/10/2019

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: 10/27/2018
• Device Catalogue Number: 07P50-20
• Device Lot Number: 86372UI00
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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 ANALYZER; ALINITY I ANALYZER; LN 03R65-01 SN AI01253; LN 03R65-01 SN AI01253