MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS TSH (3RD IS); 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	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The access tsh reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this incident.A sample of the patient's specimen was sent to the complaint handling unit for investigation.Interference testing was performed using different blockers.The blockers used in the interference testing consist of pool 1 (polymak 33 and hbr-1) and pool 2 (goat, mouse, rabbit and bovine iggs) which are animal derived antibodies.Scavenger alp, a blocker related to alkaline phosphatase, was also tested.Interference antibodies interaction are listed in the limitations section of the tsh instructions for use.This interference testing did not allow to detect interference since none of the blockers used modified the signal.The access tsh reagent was not returned for evaluation.System performance indicators have been passing within specification.The cause of this incident cannot be determined with the available information.(b)(4).
Event or Problem Description
The customer reported obtaining reproducible elevated tsh (access tsh) results for one patient generated on the laboratory's unicel dxi 800 access immunoassay system, serial number (b)(4).There was a report of a change in patient treatment due to the falsely elevated access tsh results.The patient was administered thyroxine.There were no issues with sample integrity.Calibration and quality control were within range at the time of the event.

• Brand Name: ACCESS TSH (3RD IS)
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills; clare ; EI
• MDR Report Key: 8299443
• Report Number: 9680746-2019-01002
• Device Sequence Number: 2462632
• Product Code: JLW
• UDI-Device Identifier: 15099590671495
• UDI-Public: (01)15099590671495(17)190630(11)180630(10)871114
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 02/01/2019

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: 06/30/2019
• Device Model Number: B63284
• Device Catalogue Number: B63284
• Device Lot Number: 871114
• Distributor Facility Aware Date: 01/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66