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

Model Number	B63284
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access tsh reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this incident.System performance indicators such as calibration and quality control were passing within specifications at the time of the event as demonstrated in data provided by the customer.Other system verification testing such as precision runs and system check data were not provided by the customer.The access tsh reagent was not returned for evaluation.System performance indicators have been passing within specification.In conclusion, the cause of this incident cannot be determined with the available information.Beckman coulter internal identifier: case-(b)(4).
Event or Problem Description
On july 31, 2019 the customer reported that on (b)(6) 2019 an elevated tsh result was generated on the customer's unicel dxi 800 immunoassay analyzer serial number (b)(4) for one patient sample.The customer stated that the result of "around 27 uiu/ml" (verbal report) was released from the laboratory and was later questioned by a physician.The customer reported that the physician adjusted the patient's medication due to the elevated result; however, details about medication or dosage were not provided.The customer reported repeat testing of the sample was not possible as the sample was discarded.Customer reported that the physician questioned the result because it was inconsistent with historical results.Customer reported previous tsh result for patient generated in (b)(6) 2019 was 0.17 uiu/ml; customer reported a repeat tsh test of the patient performed on (b)(6) 2019 gave a result of 0.17 uiu/ml.Customer did not provide reference ranges.Beckman coulter tsh reference range is 0.45 uiu/ml - 5.33 uiu/ml.Calibration and quality control were passing at the time of the event.Customer reported system check performed on (b)(6) 2019 was within specifications.No sample collection information such as sample type, sample tube type or size, centrifugation time or speed, or any other sample processing information was provided.

• 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: 8888182
• Report Number: 2122870-2019-01111
• Device Sequence Number: 2587160
• Product Code: JLW
• UDI-Device Identifier: 15099590671495
• UDI-Public: (01)15099590671495(17)200331(11)190401(10)920745
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: B63284
• Device Catalogue Number: B63284
• Device Lot Number: 920745
• Distributor Facility Aware Date: 07/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other