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

Model Number	B63284
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Full patient identifier is case(b)(4).The customer did not provide patient demographics such as age, weight, ethnicity or race.The access tsh (3rd is) reagent was not returned for evaluation.No other patient results were called into question.There were no reports of hardware error messages or issues with other assays in connection with the event.System performance indicators such as system check and calibration were passing within specifications at the time of the event.Although review of customer-supplied data shows the customer's bio-rad level 1 qc was outside low 3sd on (b)(6) 2023 it was run on (b)(6) 2023 and passing results were obtained.In conclusion, the cause of the event cannot be determined with the available information.
Event or Problem Description
The customer reported that on (b)(6) 2023 an erroneous low tsh result (access tsh, 3rd is, part number b63284 and lot number 234374) was generated on the customer's access (access 2 immunoassay analyzer, part number 81600n and serial number (b)(4).The low tsh result of 0.068 uiu/ml released from the laboratory.There was a report of change to patient treatment in connection with this event.The customer reported the clinician started a treatment (treatment details including medication(s) and dosages not provided) for the patient.Another sample was collected from the patient on (b)(6) 2023 and was tested for tsh on an alternate platform (platform information not provided); a result of 3.177 uiu/ml was obtained.There was no information provided regarding possible repeat testing of the original sample collected from the patient on (b)(6) 2023.System performance indicators such as system check and calibration were passing within specifications at the time of the event.The customer's bio-rad level 1 qc was outside low of the 3sd ranges on (b)(6) 2023, then passed on (b)(6) 2023.There was no report of hardware errors or issues with other assays at the time of the event.Sample collection and processing information such as sample type, volume collected, storage and handling conditions, centrifugation time and speed and other sample handling information was not provided.

• 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 ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 16315370
• Report Number: 2122870-2023-00061
• Device Sequence Number: 5759492
• Product Code: JLW
• UDI-Device Identifier: 15099590671495
• UDI-Public: (01)15099590671495(17)230731(11)220731(10)234374
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K153651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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: 07/31/2023
• Device Model Number: B63284
• Device Catalogue Number: B63284
• Device Lot Number: 234374
• 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: 01/31/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2022
• 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 Age: 28 YR
• Patient Sex: Female