MAUDE Adverse Event Report: IRELAND DIAGNOSTICS DIVISION LONGFORD ALINITY PROLACTIN

Model Number	07P6630
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier = (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated and above the reference range alinity prolactin results on multiple patients.Those patient samples send out for retesting and results were negative.The results are as follow alinity, siemens and then beckman from (b)(6) 2020 sid (b)(6) female prolactin=52.96 ng/dl/17.95 ng/ml/no result.Sid (b)(6) female prolactin=33.05 ng/dl/24.77 ng/ml/no result.Sid (b)(6) female prolactin=13.02 ng/dl/8.70 ng/ml/ no result.Sid (b)(6) female prolactin=11.19 ng/dl/8.05 ng/ml/no result.Sid (b)(6) male prolactin=26.78 ng/dl/12.24 ng/ml/no result.Sid (b)(6) female prolactin=77.71 ng/dl/19.87 ng/ml/27.79 ng/ml.Sid (b)(6) female prolactin=35.0 ng/dl/ 22.11 ng/ml/ no result.Sid (b)(6) female prolactin=20.97 ng/dl/9.21 ng/ml/no result.Sid (b)(6) male prolactin=9.73 ng/dl/7.26 ng/ml/no result.Sid (b)(6) female prolactin=22.62 ng/dl/5.89 ng/ml/10.02 ng/ml.Sid (b)(6) male prolactin=31.52 ng/dl/8.77 ng/ml/no result.Sid (b)(6) female prolactin=28.48 ng/dl/12.97 ng/ml/no result.(b)(6) year old female prolactin=18.14 ng/dl/ 12.52 ng/ml/no result.(b)(6) year old female prolactin=33.50 ng/dl/24.66 ng/ml/no result.(b)(6) year old male prolactin=66.86 ng/dl/34.18 ng/ml/no result.(b)(6) year old male prolactin=34.10 ng/dl/22.34 ng/ml/no result.(b)(6) year old menopause female prolactin=2.97 ng/dl/2.01 ng/ml/no result.(b)(6) year old female prolactin=54.51 ng/dl/38.72 ng/ml/no result.(b)(6) year old female prolactin=20.75 ng/dl/11.66 ng/ml/no result.Sid (b)(6) female prolactin=110.45 ng/dl/30.8 ng/ml/37.23 ng/ml.Sid (b)(6) female prolactin=83.99 ng/dl/72.6 ng/ml/73.92 ng/ml.Sid (b)(6) female prolactin=38.27 ng/dl/29.0 ng/ml/27.45 ng/ml.Sid (b)(6) female prolactin=76.77 ng/dl/34.8 ng/ml/39.92 ng/ml.There was no reported impact to patient management.Per dfp01.014 edition 021, falsely elevated prolactin results with a shift >25% are reportable.
Additional Manufacturer Narrative
A search of complaints for alinity i prolactin assay, lot 10355ui00 identified no similar complaints and no trends for the customer's issue.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.File samples were tested, and all validity and acceptance criteria have been met within their established limits and comparable with other lots in the field and confirms no systemic issue for the lot.All specifications were met indicating the lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the alinity i prolactin assay for lot 10355ui00 was identified.

• Brand Name: ALINITY PROLACTIN
• Common Device Name: PROLACTIN
• Manufacturer (Section D): IRELAND DIAGNOSTICS DIVISION LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• MDR Report Key: 10489288
• Report Number: 3005094123-2020-00196
• Device Sequence Number: 11401212
• Product Code: CFT
• UDI-Device Identifier: 00380740121587
• UDI-Public: 00380740121587
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/07/2020

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: 09/25/2020
• Device Model Number: 07P6630
• Device Catalogue Number: 07P66-30
• Device Lot Number: 10355UI00
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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; ALNTY I PROCESSING MODU, 03R65-01, (B)(6); LIST # 03R65-01, SERIAL # (B)(6)