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U.S. Department of Health and Human Services

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

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BECKMAN COULTER ACCESS SENSITIVE ESTRADIOL RADIOIMMUNOASSAY, ESTRADIOL Back to Search Results
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.
 
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Brand NameACCESS SENSITIVE ESTRADIOL
Type of DeviceRADIOIMMUNOASSAY, 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 Key11614267
MDR Text Key260673623
Report Number2122870-2021-00042
Device Sequence Number1
Product Code CHP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023764
Number of Events Reported1
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 Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberB84493
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2021
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 Unkown

Patient Treatment Data
Date Received: 04/05/2021 Patient Sequence Number: 1
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