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

Model Number	33560
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access testosterone reagent was not returned for evaluation.No hardware errors or issues with other assays were reported in conjunction with this event.Qc was out high and unacceptable at the time of the event and the result was obtained with cex (calibration expired) and clx (calibrator lot expired) flags.Recalibrating with a new reagent pack resolved the issue.Although replacement of reagent pack and recalibrating the assay resolved this issue, the root cause of this event cannot be determined with the available information.The available information reasonably did not suggest a reagent or an instrument malfunction.
Event or Problem Description
On (b)(6) 2020, the customer reported obtaining a false high testosterone result (access testosterone part number 33560 and lot number 921781) for one patient involving the laboratory's unicel dxi 800 immunoassay analyzer (part number 973100 and serial number (b)(4)).The initial false high access testosterone result of 235.26 ng/dl was obtained on (b)(6) 2020.The result was obtained with cex (calibration expired) and clx (calibrator lot expired) flags.Upon repeat on (b)(6) 2020 on same analyzer with a new reagent pack and new calibration, the result was 21.76 ng/dl which was accordant with the customer expectation.The patient who has an advanced prostate cancer was administered medicine (name not provided by customer) to decrease the testosterone rate based on the erroneous elevated access testosterone result.There was no additional change to or impact to patient care reported in association with this incident.System check passed on 10nov2020.Per customer¿s verbal report, qc was out high and unacceptable at the time of the event.No hardware errors or other assay issues were reported in conjunction with this event.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.

• Brand Name: ACCESS TESTOSTERONE
• Common Device Name: RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11054740
• Report Number: 2122870-2020-00097
• Device Sequence Number: 16797020
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)210131(11)200201(10)921781
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: 01/31/2021
• Device Model Number: 33560
• Device Catalogue Number: 33560
• Device Lot Number: 921781
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/22/2020
• 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