MAUDE Adverse Event Report: BECKMAN COULTER ACCESS TSH (3RD IS); RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	ACCESS TSH (3RD IS)
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 13 sep 2023, the customer reported obtaining questioned tsh (access tsh (3rd is), part number b63284 and lot number 337248) for one patient.The customer reported obtaining questioned tsh results across several months beginning in may 2023.There was a report of change to patient treatment or management in connection with this event.The patient was on levothyroxine.The medication dosage was increased to 75 mcg after the first tsh result obtained on (b)(6) 2023.After the second tsh result obtained on (b)(6) 2023, the medication dosage was increased to 100 mcg.On 12jul2023, the physician began to question results and did not increase the dosage further.There was no further report of change to patient treatment or injury to the patient in connection with this event.Patient tsh results were reported to be discordant to the patient's clinical file.The patient was undergoing treatment that should see tsh values go down over course of treatment.No hardware errors or other assay issues 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 passing within specifications at the time of the event.There were no issues reported with sample integrity.Sample collection, handling and processing information such as sample type, volume collected, centrifugation time and speed and other sample processing information was not provided by the customer.
Additional Manufacturer Narrative
A1: the full identifier for this event is (b)(4).A2, a4 and a5: the customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.H3 and h6: the access tsh reagent was not returned for evaluation.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 passing within specifications at the time of the event.In conclusion, the cause of this event cannot be determined with the available information.

• Brand Name: ACCESS TSH (3RD IS)
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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 ; 20 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613625
• MDR Report Key: 17865305
• Report Number: 2122870-2023-00090
• Device Sequence Number: 14885471
• Product Code: JLW
• UDI-Device Identifier: 15099590671495
• UDI-Public: (01)15099590671495(17)240331(11)230401(10)338248
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K153651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: ACCESS TSH (3RD IS)
• Device Catalogue Number: B63284
• Device Lot Number: 338248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female