MAUDE Adverse Event Report: QUALIGEN, INC. FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUES; PROSTATE - SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  malfunction  

Event Description

Urologist tested me for my psa, prostate specific antigen using in doctor's office, the fast pack ip system office analyzer for determining my psa value.This in office psa test was performed, one on the separate occasions, 2 different urologists and 2 different fastpack analyzers.In addition, i also obtained psa values using off site labs, using my va and other health insurance.The psa results are in block 5 of this form.During the first round of testing, the fastpack ip psa results were almost double the 2 traditional lab results.During the second round of test results, the fastpack ip results were again very high compared to the traditional lab results for psa.Possible inflated psa values may lead to inappropriate treatments for low risk prostate cancer.

• Brand Name: FASTPACK IP SYSTEM - IN DOCTOR'S OFFICE ANALYZER FOR PSA VALUES
• Type of Device: PROSTATE - SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• Manufacturer (Section D): QUALIGEN, INC.
• MDR Report Key: 8164653
• MDR Text Key: 130665128
• Report Number: MW5082129
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/03/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 82