MAUDE Adverse Event Report: CHASKA DISCRETE MFG IO ACCESS TESTOSTERONE REAGENT; RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE

Model Number 33560

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).The access testosterone reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.The customer performed quality control (qc), system check and precision testing post-event and all results were within instrument and assay specifications.A beckman coulter (bci) field service engineer (fse) was not dispatched to the customer's laboratory as no hardware or system issues were in question.In conclusion, the cause of the elevated access testosterone result could not be determine with the information supplied.A definitive cause is unknown and unknowable at this time.

Event Description

The customer contacted beckman coulter (bci) on (b)(6) 2019 to report obtaining an elevated testosterone (access testosterone) result for one (1) patient on the laboratory's access 2 immunoassay analyzer, serial number (b)(4).The patient's sample was collected on (b)(6) 2019 and tested on (b)(6) 2019.The initial access testosterone result was significantly elevated.The same sample was reanalyzed on the same access 2 immunoassay analyzer and a lower result was obtained.The customer noted that on (b)(6) 2019 the patient was redrawn and tested again on the access testosterone assay which subsequently produced a result that matched the lower of the two (2) results obtained from the original sample.The customer stated that there was a change to patient treatment/management as this particular patient's hormone replacement therapy was cancelled due to the initial, elevated access testosterone result obtained.There was no report of an injury or death attributable to this event.System performance indicators such as quality controls (qc), calibrations, precision testing and system checks were passing within instrument and assay specifications after the event.There was no report of hardware issues or issues with other assays at the time of the event.The patient's sample was collected in a serum tube with a gel separator.Centrifugation information such as centrifugation time and speed were not supplied.There were no reports of pre-analytical issues with the sample or issues with sample handling in conjunction with this event.

• Brand Name: ACCESS TESTOSTERONE REAGENT
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• Manufacturer (Section D): CHASKA DISCRETE MFG IO; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 9453132
• MDR Text Key: 185510430
• Report Number: 2122870-2019-01146
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)200630(11)190701(10)920997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001935
• 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: 12/11/2019

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: 06/30/2020
• Device Model Number: 33560
• Device Catalogue Number: 33560
• Device Lot Number: 920997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/15/2019
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2019
• 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