MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TESTOSTERONE, TOTAL; 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	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.The access testosterone, total reagent was not returned for evaluation.All assay and system verifications met specifications at the time of this event.No hardware errors, flags or other assay issues were reported in conjunction with this event.The access testosterone, total result obtained on the access 2 immunoassay system was discordant with testosterone testing results obtained on a competitor instrument and the patient's clinical presentation.In conclusion, the root cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2019 the customer reported that on (b)(6) 2019 an elevated testosterone (access testosterone, total) result had been generated on the customer's access 2 analyzer (serial number (b)(4)) for one patient sample.The initial elevated access testosterone, total result of >0.75 mg/ml was released from the laboratory.The customer reported administering medication to the patient in order to decrease the testosterone level; however, the details of what medication was administered was not provided.There was no additional change to or impact to patient care reported in association with this event.The customer reported retesting the sample on a competitor device and obtained a lower result.The customer did not provide the results or a reference range for the competitor device.Calibration was passing at the time of the event.System check was performed on (b)(6) 2019 and passed within specifications.No sample collection information such as sample type, sample tube type or size, centrifugation time or speed or any other sample processing information was provided.

• Brand Name: ACCESS TESTOSTERONE, TOTAL
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8535856
• Report Number: 2122870-2019-01071
• Device Sequence Number: 16580373
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)190831(11)180831(10)831937
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083867
• 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): 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 33560
• Device Catalogue Number: 33560
• Device Lot Number: 831937
• Distributor Facility Aware Date: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/22/2019
• 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