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

Catalog Number 33560

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

The full identifier for this event is case (b)(4).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The customer did not provide a lot number; therefore, a date of expiration and udi could not be obtained.The customer did not provide a lot number; therefore, a date of manufacture could not be obtained.The access testosterone reagent was not returned for evaluation.There were no hardware errors or issues with other assays reported on conjunction with this event.System performance indicators such as system check, calibrations and quality control were not provided for review.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer stated discrepant testosterone (access testosterone, part number 33560, lot number not provided) results were generated on the customer's dxi (dxi 800 access immunoassay analyzer, part number a71456 and serial number (b)(4)) for an unspecified number of patients.Date or dates of testing were not provided by the customer.The results were released from the laboratory.There was a report of change to patient care or management which occurred in conjunction with this event.The customer reported the patients received estrogen blockers; however, estrogen blocker information such as manufacturer and dose were not provided.There was no further information available regarding patient treatments.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.Sample collection and processing information such as sample type, volumes collected, centrifugation time and speed, storage or other sample information was not provided.

• 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 55318 ; 9523681224
• MDR Report Key: 12307828
• MDR Text Key: 266032574
• Report Number: 2122870-2021-00126
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021

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 Catalogue Number: 33560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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