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

Model Number	33560
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• Manufacturer (Section D): CHASKA DISCRETE MFG IO; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 9453132
• Report Number: 2122870-2019-01146
• Device Sequence Number: 16913499
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)200630(11)190701(10)920997
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K001935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Distributor Facility Aware Date: 11/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other