FDA Adverse Event Malfunction Summary report: N

AIA-2000ST

MDR report key: 7300435 · Received February 27, 2018

Report

Report Number: 8031673-2018-01710
Event Type: Malfunction
Date Received: February 27, 2018
Date of Event: August 27, 2015
Report Date: February 27, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED WHO FOUND TUBING FROM WASH SYRINGE TO SOLENOID KINKED. FSE ALSO REPLACED THE WORN SYRINGE PUMP. CUSTOMER CONTROLS IN RANGE. NO FURTHER ACTION REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A DEFECTIVE WASH PROBE/VALVE. TOSOH BIOSCIENCE, INC. IS SUBMITTING ON BEHALF OF THE FOREIGN MANUFACTURER, TOSOH CORPORATION, PER EXEMPTION NUMBER E2017013. THIS REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED UNDER CAPA-2017-0007. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE IMPORTER OR MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem · 0

ON (B)(6) 2015, A CUSTOMER REPORTED WASH PROBE PURGE FAILURE WITH THEIR AIA-2000ST ANALYZER. CUSTOMER CLEANED PROBES, CHANGED TIPS, CHECKED CONNECTIONS, CLEANED LEVEL SENSORS WITH NO RESOLUTION. THE CUSTOMER WAS UNABLE TO RUN BHCG,E2,CTNL2 AND PTH PATIENT SAMPLES. ON (B)(6) 2015 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING BHCG,E2,CTNL2 AND PTH PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
142850	AIA-2000ST	AIA-2000ST	KHO	TOSOH CORPORATION	AIA-2000ST

Patients

Seq	Age	Sex	Outcome	Treatment
1