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

Catalog Number 07P93-20

Device Problem Low Test Results (2458)

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

Event Date 04/02/2024

Event Type  malfunction  

Event Description

The customer observed falsely depressed total and free psa results on the alinity i processing module, serial number ai25062.The sample was repeated after centrifuging again and the results were higher.The patient has been diagnosed with chronic cardiac failure, atrial fibrillation.Prostatic hypertrophy, and chronic bronchitis.The patient takes anticoagulants and antithrombotic drugs, pradaxa, clarithromycin, silodosin, and spironolactone.The following data was provided: (b)(6) (b)(6) 2024 12:37: total psa = 0.5 ng/ml free psa = 0.053 ng/ml (b)(6) 2024 13:21: total psa = 78.582 ng/ml free psa = 8.479 ng/ml no impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier = (b)(6).

• Brand Name: ALINITY I FREE 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: 19183502
• MDR Text Key: 341128122
• Report Number: 3008344661-2024-00050
• Device Sequence Number: 1
• Product Code: MTG
• UDI-Device Identifier: 00380740130329
• UDI-Public: (01)00380740130329(17)240520(10)53077FN00
• 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
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2024
• Device Catalogue Number: 07P93-20
• Device Lot Number: 53077FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).