MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TESTOSTERONE; RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Catalog Number	33560
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: full patient identifier is (b)(6).A2, a4 and a5: the customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.H3 and h6: the access testosterone reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.An aliquot of the patient sample was forwarded to the beckman coulter complaint handling unit (chu).Initial dilution testing performed by chu suggested presence of interferent; however, chu interference testing did not demonstrate presence of interferents in the sample.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On 20 july 2023 the customer reported obtaining erroneous repeatable elevated testosterone (access testosterone, part number 33560 and reagent lot number 338265) on their access (access 2 immunoassay analyzer, part number 81600n and serial number (b)(6)) for one patient beginning in (b)(6) 2023.The elevated testosterone results were released from the laboratory.There was a report of change to patient treatment or management in connection with this event.The customer reported the patient received an injection of firmagon on (b)(6) 2023 (dose administered not provided).There was no further report of change to patient treatment or management in connection with this event.Customer stated another sample was collected and sent to a reference lab (b)(6); lower results were obtained.Customer did not know reference lab testing methodology.Customer also reported sending a sample to another laboratory, (b)(6) laboratory and reported results of testing performed at (b)(6) laboratory matched the results obtained at quest.Customer reported the (b)(6) laboratory used a roche platform.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.There were no issues reported with sample; sample type, volume collected, sample handling and processing information were not provided by the customer.The customer agreed to send sample to the beckman coulter complaint handling unit (chu) for interference testing.

• Brand Name: ACCESS TESTOSTERONE
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• 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: 17509906
• Report Number: 2122870-2023-00087
• Device Sequence Number: 7943464
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)240331(11)230401(10)338265
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 33560
• Device Lot Number: 338265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male