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

Model Number	33820
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, gender, date of birth, weight, ethnicity or race.The access tsh 3rd is reagent was not returned for evaluation.All assay and system parameters were within specification at the time of the event.No hardware errors, flags or other assay issues were reported in conjunction with this event.The cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2019, the customer reported obtaining non-reproducible ftsh2 (access tsh (3rd is)) results for one patient involving the laboratory's access 2 immunoassay analyzer (serial number (b)(4)).The initial elevated access tsh result of 41.56 uiu/ml was released from the laboratory.The customer's normal reference range was not provided.The patient was subsequently administered thyroid medication.There was no additional change to or impact to patient care reported in association with this event.Calibration and quality control were all recovering within expected parameters at the time of the incident.Details regarding sample type, sample handling and centrifugation were not provided.No sample integrity issues were noted.

• Brand Name: ACCESS TSH (3RD IS) REAGENT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8345500
• Report Number: 2122870-2019-01047
• Device Sequence Number: 19299517
• Product Code: JLW
• UDI-Device Identifier: 15099590575311
• UDI-Public: (01)15099590575311(17)190831(11)180831(10)831964
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 08/31/2019
• Device Model Number: 33820
• Device Catalogue Number: B63284
• Device Lot Number: 831964
• Distributor Facility Aware Date: 01/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other