MAUDE Adverse Event Report: CHASKA DISCRETE MFG IO ACCESS THYROGLOBULIN; ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Model Number	33860
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide patient demographics such as date of birth, weight, ethnicity or race.The access thyroglobulin reagent was not returned for evaluation.All assay and system verifications met specifications at the time of this incident.No hardware errors, flags or other assay issues were reported in conjunction with this event.One patient sample was sent to the beckman coulter complaint handling unit (chu) for investigation.Patient sample was first tested neat after centrifugation for the access thyroglobulin assay.The chu obtained a high access thyroglobulin result.Customer's results were therefore confirmed.An interference testing, using different blockers, was then carried out.The blockers used in the interference testing 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 access thyroglobulin instructions for use.This interference testing demonstrated the presence of interfering substances since animal derived antibodies used in the test significantly lowered the signal.The cause of this event is a patient source interferent.
Event or Problem Description
On (b)(6) 2018 the customer reported that reproducible elevated thyroglobulin (access thyroglobulin) results had been generated on the customer's unicel dxi 800 access immunoassay system (serial number (b)(4)) for one patient.The elevated access thyroglobulin results were released from the laboratory.The patient's samples were analyzed utilizing other methodologies and recovered with negative results.Actual results were not provided.There was a report of change to patient care or treatment which occurred in connection with this event.The patient underwent mri (magnetic resonance imaging).There was no report of further injury or change to patient management reported in this event.Calibration, quality control and system check were all performing within specifications at the time of the incident.Information regarding patient sample collection and processing was not provided.

• Brand Name: ACCESS THYROGLOBULIN
• Common Device Name: ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
• Manufacturer (Section D): CHASKA DISCRETE MFG IO; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8206504
• Report Number: 2122870-2018-01037
• Device Sequence Number: 2069922
• Product Code: MSW
• UDI-Device Identifier: 15099590227173
• UDI-Public: (01)15099590227173(17)190930(11)171012(10)724117
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031269
• 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): 12/31/2018

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 Model Number: 33860
• Device Catalogue Number: 33860
• Device Lot Number: 724117
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR