MAUDE Adverse Event Report: BECKMAN-COULTER ACCESS FT3 REAGENT; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Catalog Number	A13422
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer did not provide patient demographics such as age, date of birth, gender or weight.All system and assay parameters were performing within specification.There were no errors or flag associated with this event.The access ft3 reagent was not returned for evaluation.The cause of this event cannot be determined with the available information.(b)(4).
Event or Problem Description
The customer reported obtaining a false high access ft3 (free triiodothyronine) result on their unicel dxi 800 access immunoassay system (serial number (b)(4)) for one patient.The initial result recovered above the assay reference range.The result was released out of the laboratory.There was no report of change in patient treatment associated with this event.The customer re-analyzed the patient's sample using three (3) different methodologies, and recovered with lower results.The sample was re-analyzed on an abbott architect system, a fujirebio lumipulse system and an unidentified third methodology.The sample was collected in a serum separator tube and centrifuged for five (5) minutes at 3000 rpm (revolutions per minute).There was no report of sample integrity issues.Calibration, quality control (qc) and system check parameters met assay and system specifications.
Additional Manufacturer Narrative
Adverse event and/or product problem: no malfunction.The customer provided one patient sample to beckman coulter (bec) complaint handling unit (chu) for interference testing.Bec chu initial internal testing of the provided sample yielded an access free t3 result which was above the assay's normal expected values; thus customer's results were confirmed.Further internal functional testing demonstrated that biotin and/or anti-streptavidin interference was the cause of the reported elevated and discordant ft3 results.Per the ft3 ifu, part number a33730 g, "patient with biotin (vitamin h) treatment may have elevated free t3 levels due to displacement of the biotinylated t3 analog from paramagnetic particles coated with streptavidin." in conclusion, a patient source interferent is the cause of this event.

• Brand Name: ACCESS FT3 REAGENT
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): BECKMAN-COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 6129046
• Report Number: 2122870-2016-00555
• Device Sequence Number: 731282
• Product Code: CDP
• UDI-Device Identifier: 15099590201661
• UDI-Public: (01)15099590201661(17)161231(11)NO-DATA(10)534336
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: A13422
• Device Lot Number: 534336
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 12/12/2016
• Patient Sequence Number: 1