MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SENSITIVE ESTRADIOL; RADIOIMMUNOASSAY, ESTRADIOL

Catalog Number B84493

Device Problem Low Test Results (2458)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

The full patient identifier for this report is case (b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.Customer did not provide a reagent lot number; therefore, lot number, a reagent expiration date or a udi could not be provided.Customer did not provide a reagent lot number; therefore, reagent manufacture date could not be provided.The access sensitive estradiol reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.There is insufficient evidence to suggest a reagent or hardware malfunction occurred in this event.In conclusion, the cause of this event cannot be determined with the information supplied.

Event Description

On (b)(6) 2021 the customer reported that in (b)(6) 2021, low sensitive estradiol (access sensitive estradiol) results which had been generated on the customer's access 2 (access 2 immunoassay system, part number 81600n and serial number (b)(4)).The customer reported there was a delay to treatment but declined to provide information regarding specific details of delay to treatment.The customer has since resumed treatment for the patient.There was no additional report of change to patient treatment, patient treatment or management in association with this event.Customer did not provide sensitive estradiol test dates or results.No hardware errors or issues with other assays were reported in conjunction with this event.Customer declined to provide system performance information such as system check, calibrations or quality control test results.Samples were allowed to clot for 30 minutes and centrifuged for 15 minutes.No other sample collection, handling or processing information was provided.

• Brand Name: ACCESS SENSITIVE ESTRADIOL
• Type of Device: RADIOIMMUNOASSAY, ESTRADIOL
• 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: 11614267
• MDR Text Key: 260673623
• Report Number: 2122870-2021-00042
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: B84493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2021
• 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