MAUDE Adverse Event Report: BECKMAN COULTER ACCESS PSA; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number 37200

Device Problem High Test Results (2457)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

The full patient identifier is (b)(6).The customer did not provide patient demographics such patient date of birth, weight, ethnicity or race.The beckman psa reagent was not returned for evaluation.The available information does not reasonably suggest that the system has malfunctioned.No hardware errors, flags or other assay issues were reported.The patient's sample was tested by the complaint handling unit.The testing did not confirm that a patient source interferent was the cause of the elevated result.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2022 the customer reported that in (b)(6) 2021, an erroneous reproducible elevated psa (access psa, part number 37200 and lot number 124120) was generated on the customer's dxi (unicel dxi 600 access immunoassay analyzer, part number a30260 and serial number (b)(4)).The erroneous elevated result of 23.4 ng/ml was reported out of the laboratory.There was a report of change to patient treatment or management in connection with this event.The patient underwent a prostate biopsy in (b)(6) 2021.The customer was unable to provide exact dates for test results or prostate biopsy procedure.There was no report of additional change to patient treatment or management which occurred in connection with this event.No hardware errors or issues with other assays were reported in conjunction with this event.No quality control issues were reported in connection with the event.No other patient results were called into question.Sample collection and handling information such as sample type, volume drawn, centrifugation time and speed, and other information was not provided by the customer.

• Brand Name: ACCESS PSA
• Type of Device: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 13595734
• MDR Text Key: 286532828
• Report Number: 2122870-2022-00009
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 15099590224592
• UDI-Public: (01)15099590224592(17)220331(11)210331(10)124120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 37200
• Device Lot Number: 124120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male