MAUDE Adverse Event Report: BECKMAN COULTER ACCESS FREE T4; RADIOIMMUNOASSAY, FREE THYROXINE, PRODUCT CODE CEC

Catalog Number	33880
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, gender, weight, ethnicity, and race.The access free t4 reagent was not returned for evaluation.A beckman coulter field service engineer (fse) was dispatched to the customer's site to evaluate the system.No hardware malfunction was detected.No hardware errors, flags or other assay issues were reported in conjunction with this event.In conclusion: the cause of the low access free t4 result cannot be determined with the available information.
Event or Problem Description
The customer reported obtaining a low free thyroxine (access free t4) result for one (1) patient involving one of two unicel dxi 800 access immunoassay systems (serial (b)(4)).The customer could not provide information on which of the two analyzers were in use for this event.The low access free t4 result was released from the laboratory.A physician indicated there was a change made to patient medication, for one patient; however, no further details are available.The customer provided additional questioned low access free t4 results for twenty six (26) patient samples, it is unknown which patient was affected by the change to medication.Quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event.No hardware errors, flags or other assay issues were reported in conjunction with this event.The patient sample was serum, collected in a serum separator tube with gel.The customer did not provide additional sample collection and handling information such as centrifugation speed and time.No issues with sample integrity were reported.A beckman coulter field service engineer (fse) fse was dispatched to evaluate instrument performance.

• Brand Name: ACCESS FREE T4
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE, PRODUCT CODE CEC
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 6820769
• Report Number: 2122870-2017-00041
• Device Sequence Number: 65502
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)190228(11)170225(10)633003
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K982250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 33880
• Device Lot Number: 633003
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other