MAUDE Adverse Event Report: BIOREFERENCE HEALTH, LLC 4KSCORE TEST

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Date 10/07/2022

Event Type  malfunction  

Event Description

A 58-year-old male with a history of high level of prostate specific antigen (psa).Submitted a sample for 4kscore test analysis on (b)(6) 2022, which was conducted on (b)(6) 2022.The subject's urological history included a previous digital rectal exam without a prostate nodule present.The subject also had a previous biopsy that was negative.His 4kscore was 12.2 and this result was reported, to the requistioner/provider on (b)(6) 2022.Given the identification of the input error in the sample requisition intake software, his 4kscore was recalculated and reported, to the physician on (b)(6) 2022, with a revised 4kscore of 2.2, 41 days after the initial result report.Clinical follow-up: unknown/healthcare provider declined to provide follow-up.Given that the initial 4kscore result was 20, and decreased further upon recalculation to 10,.There is a remote possibility that the subject, was subjected to additional and potentially unnecessary medical procedures which may include magnetic resonance imaging of the prostate and/or biopsy, and the risks associated with that, as deemed necessary by the attending physician.To date, neither the pma holder nor the manufacturer has received or is aware of any untoward events/effects as a result of this device malfunction and errant initial 4kscore test results.This one device malfunction impacted (b)(6) test results.Please refer to section h10 in manufacturer's report no.3003652672-2022-00001.For a complete discussion with respect to the late filing date and description of the device malfunction.

Manufacturer Narrative

This one device malfunction impacted (b)(6) test results.Please refer to section h10 in manufacturer's report no.3003652672-2022-00001.For a complete discussion with respect to the late filing date and description of the device malfunction.Please refer to this noted report for all other common information that is not specific to this subject's case.

• Brand Name: 4KSCORE TEST
• Type of Device: 4K
• Manufacturer (Section G): BIOREFERENCE HEALTH, LLC; 481 edward h. ross dr; elmwood park NJ 07407
• Manufacturer Contact: jane hsiao ; 4400 biscayne blvd; miami, FL 33137 ; 3055756004
• MDR Report Key: 16959478
• MDR Text Key: 315560907
• Report Number: 3003652672-2022-00282
• Device Sequence Number: 1
• Product Code: QRF
• Combination Product (y/n): N
• PMA/PMN Number: P190022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Removal/Correction Number: 3003652672-04/12/2023-00
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male