MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL PSA REAGENT KIT; PROSTATIC SPECIFIC ANTIGEN (PSA)

Catalog Number	07P92-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
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.There is no further patient information provided due to privacy issues.This report is being filed on an international product, list number 7p92 that has a similar product distributed in the us, list number 6c06.
Event or Problem Description
The customer reported falsely elevated alinity i total psa results on one patient.The results provided were: on (b)(6) 2019 sid (b)(4) = 4.96ug/l (diagnostic range 0.0 - 3.9ug/l).The patient is being monitored post prostate cancer treatment and his previous results were less than 0.01ug/l.Repeat sample on (b)(6) 2020 = less than 0.01ug/l.There was no reported impact to patient management.
Additional Manufacturer Narrative
A review of complaint tickets for the assay nor testing could be completed as the lot is unknown.A review of complaints determined there are no trends for the product for the complaint issue.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i total psa assay.
Additional Manufacturer Narrative
Suspect medical device, 4.Catalog# from 07p92-31 to 07p92-30; udi from (b)(4) to (b)(4).

• Brand Name: ALINITY I TOTAL PSA REAGENT KIT
• Common Device Name: PROSTATIC SPECIFIC ANTIGEN (PSA)
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9695211
• Report Number: 3008344661-2020-00014
• Device Sequence Number: 11353343
• Product Code: MTF
• UDI-Device Identifier: 00380740158323
• UDI-Public: 00380740158323
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07P92-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 03/19/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/05/2020; 03/24/2020
• 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, LN 03R65-01,; ALINITY I PROCESSING MODULE, LN 03R65-01,; ALINITY I PROCESSING MODULE, LN 03R65-01,; SERIAL # (B)(6) ; SERIAL # (B)(6) ; SERIAL # AI01139
• Patient Age: 65 YR