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

Catalog Number 37200

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics such as age, date of birth, weight, race and ethnicity were not supplied.A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's laboratory to assess instrument performance as the customer was not questioning the performance in conjunction with this event.All of the system parameters, including quality controls (qc), calibrations and system checks were performing with instrument specifications at the time of the event.The access hybritech psa reagent was not returned to bec for further investigation.No further information is available regarding the performance of the reagent.There were no reports of error messages, system flags or issues with other patients/assays in conjunction with this event.The customer sent the patient's sample to the bec complaint handling unit (chu) in (b)(4) for further investigative testing.The bec chu performed initial neat sample testing and obtained a significantly lower result than the customer.The customer's event could not be confirmed.Further evaluation of the patient's sample was not warranted.In conclusion, the cause of this incident is unknown and unknowable with the information supplied.

Event Description

The customer reported obtaining a higher than expected prostate-specific antigen (access hybritech psa) result for one (1) patient on the laboratory's unicel dxi 800 access immunoassay system (serial (b)(4)).The physician questioned the result as the patient had previously undergone a radical prostatectomy (date of procedure is unknown).On (b)(6) 2017, the patient's prostate-specific antigen (psa) was tested at a reference laboratory ((b)(6)) on an alternate methodology (roche) and a significantly lower result was obtained.Another sample from this patient was also tested at a second reference laboratory (quest), on (b)(6) 2017, on a unicel dxi 800 access immunoassay system (serial number unknown) and a second higher than expected result was obtained.On (b)(6) 2017 another sample from the patient's was collected and sent to the beckman coulter (bec) complaint handling unit (chu) for testing.The customer stated the initial access hybritech psa result was reported outside the laboratory.The patient underwent an unknown hormone therapy as a result of the higher than expected access hybritech psa result obtained.The hormone therapy was discontinued once it was determined that the patient's psa results did not significantly change.The customer noted that the access hybritech psa quality controls (qc), assay calibration, and system check were performing within specifications at the time of the event.There were no error messages, hardware issues or other assay problems reported in conjunction with this event.The patient's sample was collected in a plastic serum tube with a gel separator and analyzed from the primary tube.Specific sample information was not supplied such as centrifugation time and speed.The customer did not report any issues with sample integrity.

• Brand Name: ACCESS HYBRITECH PSA REAGENT
• 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 kilian ; 1000 lake hazeltine drive; chaska, MN 55318
• MDR Report Key: 6968743
• MDR Text Key: 89960000
• Report Number: 2122870-2017-00052
• Device Sequence Number: 1
• Product Code: LTJ
• UDI-Device Identifier: 15099590224592
• UDI-Public: (01)15099590224592(17)180531(11)170603(10)723528
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 37200
• Device Lot Number: 723528
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2017
• 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