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

Catalog Number	B63284
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: the full patient identifier is case-(b)(6).The number of patients impacted was not specified.The customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.H3 and h6: no hardware errors and other assay issues were reported in conjunction with this event, per customer verbal reported, system performance indicators such as system check, calibration and quality control (qc) were passing within expectations at the time of the event.A beckman coulter laboratory solution specialist (lss) was dispatched to customer site on 18jun2024.The lss performed a passing sample comparison between the dxi analyzer and the roche methodology using twenty (20) beckman patient samples and twenty (20) patient samples from an external hospital to evaluate the consistency between the two platforms.The lss also explained to customer that difference in results between two different platforms may be observed.Beckman coulter and other manufacturers trace themselves back to their own working material while other manufacturers may be standardized against an international standard.This created differences in results between methods.In conclusion, a definitive cause for this issue cannot be determined with the available information.There is malfunction as original result is discordant with one replicate measurement of the same specimen on another methodology and patient clinical file.
Event or Problem Description
Customer reported obtaining false high access tsh (3rd is) patient results involving the laboratory's unicel dxi 800 access immunoassay analyzer (serial number (b)(6).The number of patients impacted was not specified.No data was provided.Per customer verbal report, the access tsh patient results were discordant with an alternate methodology (roche platform with lower results) and clinical expectations.There was a report of delay to patient treatment in connection with this event.The customer reported that the false high tsh results affected the process of in vitro fertilization (ivf) patients.The normal cycle for ivf patients is first sex hormones and tsh testing.If the tsh result is less than 4 mu/l, ovulation induction is performed.The customer reported that if the tsh result is more than 4 mu/l, there is a possibility of hypothyroidism in pregnancy and in order to avoid it, which also could lead to miscarriage, the ivf process is suspended.No further information was provided.No hardware errors and other assay issues were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were not provided for review.Per originator's verbal report, system performance indicators were passing within specifications at the time of the event.A beckman coulter laboratory solution specialist (lss) was dispatched to customer site on 18jun2024.There were no issues with sample integrity reported by the customer.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.No further sample information was 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: 19690866
• Report Number: 2122870-2024-00036
• Device Sequence Number: 7156453
• Product Code: JLW
• UDI-Device Identifier: 15099590671495
• UDI-Public: (01)15099590671495(17)250131(11)240201(10)339116
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 07/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: B63284
• Device Lot Number: 339116
• 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: 06/17/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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