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

Model Number 33560

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

Event Type  Injury  

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 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
• 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: harry long ; 1000 lake hazeltine drive; chaska, MN ; 9523681224
• MDR Report Key: 11054740
• MDR Text Key: 228999119
• Report Number: 2122870-2020-00097
• Device Sequence Number: 1
• Product Code: CDZ
• UDI-Device Identifier: 15099590231347
• UDI-Public: (01)15099590231347(17)210131(11)200201(10)921781
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/15/2020
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2020
• 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