MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS TSH (3RD IS); RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number B63284

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 01/15/2019

Event Type  Injury  

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 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)
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills; clare ; EI
• Manufacturer (Section G): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills; clare ; EI
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8299443
• MDR Text Key: 134857168
• Report Number: 9680746-2019-01002
• Device Sequence Number: 1
• Product Code: JLW
• UDI-Device Identifier: 15099590671495
• UDI-Public: (01)15099590671495(17)190630(11)180630(10)871114
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K153651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: B63284
• Device Catalogue Number: B63284
• Device Lot Number: 871114
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/16/2019
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66