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	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 22mar2024 the customer reported repeatable erroneously elevated testosterone results (access testosterone, part number 33560, lot number 338858) were generated for one patient on the customer's unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(6)).The elevated access testosterone results were discordant with low roche and siemens results and with the patient clinical file.Per customer verbal report, the expected values were closed to zero.The patient (transgender man) stopped his treatment (testogel) based upon the elevated access results.The erroneously elevated access testosterone result was 2.67 ng/ml on (b)(6) 2024.Per the field application specialist (fas) verbal report, this result was found similar when repeated at different days and on an alternate dxi instrument (from another laboratory).The sample was repeated with the roche methodology with a lower result (less than 0.20 ng/ml) on (b)(6) 2024 and with the siemens methodology with a result at 0 ng/ml.A second sample from this patient was tested.The patient was under treatment with testogel.The access testosterone result was 8 ng/ml and the roche testosterone result (from an alternate laboratory) was 2 ng/ml.No hardware errors or issues with other assays were reported in conjunction with this event.System check passed on 04jan2024 and 17jan2024.Quality controls (qc) were passing within the laboratory¿s established ranges between 14mar2024 and 21mar2024.No qc data at the time of the event was provided.No issue about sample integrity was reported by the customer.The fas assisted the customer over the phone.An interference was suspected because the customer obtained non-linear results when the sample was diluted.Per testosterone technical assay guide (tag), it states: ¿use of testosterone hand cream by laboratory personnel can interfere with assay results.¿ a patient sample has been sent to the complaint handling unit (chu) for interference testing.
Additional Manufacturer Narrative
A1: full patient identifier is case-(b)(4).A2, a4 and a5: the customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.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.A patient sample has been be sent to the chu for interference testing.Patient sample was first tested neat for the testosterone assay.The marseilles chu obtained a high result.Customer's result was therefore confirmed.Then, a dilution testing was performed.Results did not show the presence of interferences since the test was linear.An interference testing, using different blockers, was then carried out.The blockers used in the interference testing consist of goat iggs which are animal derived antibodies.Pool 3 (ap mutein, scavenger alp), a pool of blockers related to alkaline phosphatase, was also tested.Interference antibodies interaction is listed in the limitations section of the testo instructions for use.This interference testing did not allow to detect interference since none of the blockers used modified the signal.In conclusion, the investigation could not demonstrate any interference.The cause of the discordance could not be determined.In conclusion, the investigation could not demonstrate any interference.The cause of the issue could not be determined with the available information.There is evidence to reasonably suggest that a malfunction occurred in conjunction with this event because access result was both discordant with the patient clinical file and with two competitor methods.

• 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: 19124503
• Report Number: 2122870-2024-00017
• Device Sequence Number: 18225360
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)240930(11)231001(10)338858
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K223405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 33560
• Device Lot Number: 338858
• 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: 03/22/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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: Unknown