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

Catalog Number	33560
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A beckman coulter field service engineer was not dispatched to assess instrument performance.The access testosterone reagent was not returned for evaluation.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
The customer reported obtaining reproducibly elevated testosterone, total (access testosterone) results on the unicel dxi 800 access immunoassay system serial number (b)(4) and an alternate unicel dxi 800 access immunoassay system (serial number not specified) for one (1) patient.The patient was prescribed ethinylestradiol and cyproterone acetate tablets due to the high access testosterone results.The sample was also tested on a siemens analyzer and a lower result was obtained.Quality control was recovering within assay/instrument specifications.Calibrations and system information were not provided.The patient sample was serum.No centrifugation information was provided.No issues with sample integrity were reported by the customer.

• Brand Name: ACCESS TESTOSTERONE REAGENT
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 6700223
• Report Number: 2122870-2017-00035
• Device Sequence Number: 19319751
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)170731(11)160815(10)627527
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K001935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2017

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: 07/31/2017
• Device Catalogue Number: 33560
• Device Lot Number: 627527
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/11/2017
• 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