MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS HYBRITECH PSA; PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Catalog Number 37200

Device Problem High Test Results (2457)

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

Event Date 11/06/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 the customer reported obtaining one non-repeatable false elevated psa-hyb (access hybritech psa prostate specific antigen (part number 37200, lot number 372137) patient result generated on the customer's unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(6)).Per customer verbal report, the elevated result was discordant with the patient clinical file (healthy patient).The original psa hyb patient result was 60 g/l (ng/ml) on (b)(6) 2023.A second sample from the patient collected the same day gave a normal result at 1.15 g/l.A third sample was collected and tested on (b)(6) 2023, this sample gave also a normal result at 0.22 g/l.Expected values for psa-hyb assay are between 0 - 4 ng/ml.There was no report of an injury or illness to the patient attributable to the output from the device in this event.The patient underwent magnetic resonance imaging (mri) and further investigation by urologist based upon the initial access psa result (60 g/l).No hardware errors or other assay issues were reported in conjunction with this event.System check passed on 06nov2023.No calibration data was provided.Per raw data analysis, no qcf (quality control failure) flag was observed between 06nov2023 and 10nov2023.Per customer verbal report, there is no chance of patient mix up.No issues with samples integrity were reported by the customer.The sample was collected on lithium heparin plasma tube and centrifuged through dxa at 4,000g for 4 minutes.

Manufacturer Narrative

A1: the full patient identifier is case - (b)(4).A2, a4 and a5: the customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.H3 and h6: the access hybritech psa reagent was not returned for evaluation.No hardware errors or other assay issues were reported in conjunction with this event.No other patient results were called into question.Per customer verbal report, there is no chance of patient mix up.No issues with samples integrity was reported by the customer.In conclusion, the cause of this event cannot be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

• Brand Name: ACCESS HYBRITECH PSA
• Type of Device: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer (Section G): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 18214478
• MDR Text Key: 329103737
• Report Number: 9680746-2023-00008
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 15099590224592
• UDI-Public: (01)15099590224592(17)240630(11)230701(10)372137
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K974816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 37200
• Device Lot Number: 372137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Male