MAUDE Adverse Event Report: BECKMAN COULTER ACCESS THYROGLOBULIN; IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY

Catalog Number 33860

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2021

Event Type  Injury  

Manufacturer Narrative

The full identifier is (b)(6).The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.Customer did not provide a lot number; therefore, expiration date and udi cannot be provided.Customer telephone number is (b)(6).Customer did not provide a lot number; therefore, date of manufacture cannot be provided.The access thyroglobulin assay was not returned for evaluation.There were no reports of system issues at the time of the event.No hardware errors or flags were reported in conjunction with the event.System performance indicators such as system check, calibration and quality control were not provided for review.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On 12may2021 the customer reported obtaining erroneous elevated tg (access thyroglobulin (part number 33860, lot number not provided) results.The result of 11.3 ug/l, which was generated on the customer's dxi 800 (unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(4))), was released from the laboratory.The sample was subsequently retested and a result of <0.1 ug/l was obtained.The customer reported the patient underwent additional mri and cr scans.Contrast was used for both the mri and the ct scans.No further information regarding patient treatment was provided.No hardware errors or issues with other assays were reported in conjunction with this event.No other patient results were called into question.System performance indicators such as system check, calibration and quality control were not provided for review.No issues with sample integrity were reported by the customer.Sample was reported to be a serum which was aliquoted and stored frozen prior to testing, then thawed, allowed to equilibrate to room temperature, and tested.Sample was then re-frozen; prior to repeat testing, sample was thawed, vortex mixed and recentrifuged.Other sample information such as volume collected, centrifugation speed and time, or any other sample information was not provided by the customer.

• Brand Name: ACCESS THYROGLOBULIN
• Type of Device: IMMUNOCHEMICAL, THYROGLOBULIN AUTOANTIBODY
• 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: 11946740
• MDR Text Key: 254540924
• Report Number: 2122870-2021-00078
• Device Sequence Number: 1
• Product Code: JNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112933
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 33860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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