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

Catalog Number 33560

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 06/09/2017

Event Type  Injury  

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 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
• Type of Device: 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 kilian ; 1000 lake hazeltine drive; chaska, MN 55318
• MDR Report Key: 6700223
• MDR Text Key: 79593520
• Report Number: 2122870-2017-00035
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)170731(11)160815(10)627527
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K001935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 33560
• Device Lot Number: 627527
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2016
• 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