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

Model Number 33880

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

The full patient identifier is (b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access free t4 reagent was not returned for evaluation.No hardware errors or issues with other assays were reported in conjunction with this event.Per customer verbal's report, system performance indicators such as system check and calibration were passing within specifications at the time of the event.A beckman coulter field service engineer (fse) was dispatched to customer' site.There was no report of hardware parts replaced in connection with this event.The fse verified the storage conditions of the reagent packs and did not find any issues.Recalibrating with a fresh pack from same lot number resolved the issue.Although replacement of reagent pack with the same lot resolved the issue, the cause of this event could not be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported obtaining false high access free t4 (part number 33880, lot number 922166) patient results when loading a new reagent pack involving the laboratory's unicel dxi 800 access immuno analyzer (serial number (b)(4)).All free t4 patients results were discordant with other thyroid function-associated assays.No data was provided.Customer stated that eight (8) patient results were already released out of the laboratory.No further information was provided.The customer reported that one patient received inappropriate treatment due to the erroneously high free t4 result obtained.No further information was provided.No hardware errors or issues with other assays were reported in conjunction with this event.Per customer verbal's report, system performance indicators such as system check and calibration were passing within specifications at the time of the event.The customer performed a new calibration with the suspected pack and calibration failed.Per customer the rlu (relative light unit) value of point s0 was significantly different from the previous calibration.Quality control was not performed with the new reagent pack.A beckman coulter field service engineer (fse) was dispatched to the customer site.The fse checked the storage conditions of reagent packs with no finding.Recalibration with other reagent pack (same lot number) resolved the issue.There was no report of sample integrity issues.No further sample information was provided.

• Brand Name: ACCESS FREE T4
• 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: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12406208
• MDR Text Key: 272269083
• Report Number: 2122870-2021-00133
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 15099590225834
• UDI-Public: (01)15099590225834(17)220930(11)200930(10)922166
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982250
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 33880
• Device Catalogue Number: 33880
• Device Lot Number: 922166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/25/2021
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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