MAUDE Adverse Event Report: BECKMAN COULTER ACCESS THYROGLOBULIN ANTIBODY II; THYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL

Catalog Number A32898

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 the customer reported obtaining false low tg-ab (access thyroglobulin antibody ii, part number a32898, lot number not provided) results for one patient involving the laboratory's unicel dxi 800 access immunoassay analyzer (serial number (b)(6)).The patient underwent thyroid gland surgery two years ago and has been under observation by the endocrinologists two times a year for possible recurrence.Per customer verbal report, the access tg-ab results have always given low results between 0.5 and 0.9 iu/ml (expected values:< 4.0 iu/ml).The patient was due for new testing on (b)(6) 2023 and the tests have been transferred to the abbott architect analyzer.The architect gave one unexpected elevated result that was several times higher than the normal range upper limit.Then the patient sample was tested on access instrument with low results and on roche cobas instrument with high result similar to the architect methodology.So the access results obtained on (b)(6) 2023 were discordant with two alternate methodologies (roche cobas and abbott architect).No data was provided.The customer is unsure now when the patient¿s tg antibodies became elevated due to the discordant access results.The patient was urgently scheduled for additional investigations (computed tomography (ct) scan and thyroid ultrasound) that were not performed since a year.There is a possibility that a recurrence occurred during the monitoring period on the dxi which was not found in a timely manner.No further information was provided.No hardware errors or issues with other assays were reported in conjunction with this event.The archival data from the dxi is no longer available and the customer did not provide any additional data on the patient.

Manufacturer Narrative

A1: the full patient identifier is (b)(4).A2, a3, a4 and a5: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.D4 and h4: no lot number was provided: udi, expiration date and device manufacture date (indicated as (b)(6) 2000) could not be provided in this report.H3 and h6: there is malfunction as original result is discordant with 2 replicate measurements of the same specimen on other devices (roche cobas and abbott architect).No hardware errors or issues with other assays were reported in conjunction with this event.The archival data from the dxi was no longer available and the customer did not provide any additional data on the patient.No other patient results were called into question.In conclusion, a cause for this event could not be determined with the information supplied.

• Brand Name: ACCESS THYROGLOBULIN ANTIBODY II
• Type of Device: THYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL
• 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 vettel ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 18180255
• MDR Text Key: 328613339
• Report Number: 2122870-2023-00095
• Device Sequence Number: 1
• Product Code: DDC
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A32898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2000
• 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