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

Catalog Number	07P50-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Patient identifier: complete sid: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely decreased alinity i estradiol result of 352.5 ng/ml on a female patient that was questioned by the physician.Results provided: on (b)(6) 2019 (patient stimulated in vitro) = 1259.3 pg/ml; sid (b)(6), (b)(6) 2019 = 352.5 / >1000 / 2801.2 / 2914.9 pg/ml; (b)(6) 2019 = >3000 pg/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of complaint activity for lot 95187ui00 did not identify an increase.Return testing was not completed as returns were not available.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.A review of product labeling, including dilution protocols, was performed which provides appropriate information related to the customers issue.Based on the available information, no deficiency of the alinity i estradiol assay was identified.

• 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: 8768998
• Report Number: 3005094123-2019-00189
• Device Sequence Number: 1978261
• Product Code: CHP
• UDI-Device Identifier: 00380740129927
• UDI-Public: 00380740129927
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 09/25/2019

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: 07P50-30
• Device Lot Number: 95187UI00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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 LIST 03R65-01; ALINITY I ANALYZER LIST 03R65-01; SERIAL (B)(4); SERIAL (B)(4)