MAUDE Adverse Event Report: BECKMAN COULTER ACCESS FREE T4 REAGENT; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 33880

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

The customer did not supply the patients' demographics such as date of birth and weight.A beckman coulter (bec) field service engineer (fse) was not dispatched to the customer's site.No hardware errors, flags or other assay issues were reported in conjunction with this event.There is no evidence that the access free t4 reagent was returned for evaluation.The cause of this event cannot be determined with the available information.(b)(4).All mdrs associated with this report are: 2122870-2017-00022, 2122870-2017-00023.

Event Description

The customer contacted beckman coulter on march 06, 2017 to report generating reproducible, elevated free thyroxine (access free t4) and free triiodothyronine (access free t3) results for one patient on the unicel dxi 800 access immunoassay system serial numbers (b)(4).The customer could not provide information on which instrument was in use at the time of this event.The elevated results did not correlate with the reproducible thyroid-stimulating hormone (access tsh) results generated from the same patient samples, which recovered with one result below the assay's normal reference range and all other samples recovering within the access tsh normal reference range.The elevated access free t4 and access free t3 results also did not correlate with results obtained on an alternate methodology (diasorin liaison).All seven samples from the patient generated either an elevated access free t4 result, an elevated access free t3 result or an elevated result for both analytes.One accesstsh result for the patient, obtained on (b)(6) 2017, recovered below the assay's normal reference range.All other accesstsh results obtained for the patient recovered within the assay's normal reference range.A sample from the patient was sent to an alternate facility for testing on an alternate methodology (diasorin liaison xl) and lower free t4 and free t3 results, within each assay's respective normal reference range, were obtained.There was change or impact to patient care or treatment which occurred due to the reproducible elevated access free t3 and access free t4 patient results, as the patient started thyreostatic drug therapy.Quality control (qc) and calibrations were performing within assay and instrument specifications at the time of the event.Patient sample collection and processing information such as tube type and centrifugation, was not provided by the customer.This report addresses the elevated access free t4 results obtained for this patient.Mdr 2122870-2017-00022 addresses the elevated access free t3 results obtained for this patient.

• Brand Name: ACCESS FREE T4 REAGENT
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• 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: angela kilian ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681330
• MDR Report Key: 6402373
• MDR Text Key: 69868152
• Report Number: 2122870-2017-00023
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)180731(11)160817(10)671100
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 982250
• 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
• Type of Report: Initial
• Report Date: 03/06/2017

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: 07/31/2017
• Device Catalogue Number: 33880
• Device Lot Number: 671100
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2016
• 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
• Patient Age: 14 MO