MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL PSA REAGENT KIT; TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER

Catalog Number 07P92-22

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2024

Event Type  malfunction  

Event Description

The customer observed falsely decreased alinity i total psa results which questioned by the physician on one patient.The results provided were: on (b)(6) 2024 initial=0.874 ng/ml /repeated on (b)(6) 2024=5.032 ng/ml and 5.187 ng/ml /previous history=around 4 to 5 ng/ml there was no reported impact to patient management.

Manufacturer Narrative

The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, in-house testing of alinity i total psa, reagent, lot number 53642fn00.A review of tracking and trending data did not identify any related trends for the product for the issue.Return testing was not completed as returns were not available.In-house testing was performed with a retained kit of lot 53642fn00.All specifications were met indicating the lot is performing acceptably.Device history record review of lot 53642fn00 did not show any potential non-conformances, or deviations.A labelling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the alinity i total psa assay, lot number 53642fn00 was identified.

• Brand Name: ALINITY I TOTAL PSA REAGENT KIT
• Type of Device: TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18696561
• MDR Text Key: 335261367
• Report Number: 3008344661-2024-00020
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07P92-22
• Device Lot Number: 53642FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).