FDA Adverse Event Malfunction Summary report: N

AIA-2000

MDR report key: 7407362 · Received April 9, 2018

Report

Report Number: 8031673-2018-03753
Event Type: Malfunction
Date Received: April 9, 2018
Date of Event: March 16, 2016
Report Date: April 9, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

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. FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND ON 17-MAR-2016 FOUND BURNT SPMD BOARD. ORDERED A REPLACEMENT FOR NEXT DAY. ON 18-MAR-2016 REPLACED THE SPMD BOARD, PERFORMED MACRO FOR CORNER TIPS ON 6 BOXES AND MACRO FOR CORNER CUPS ON ALL SHELVES OF THE SORTER. CUSTOMER RAN QC (QUALITY CONTROL) WHICH WAS IN RANGE, WITH NO ERRORS. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A FAILURE OF THE SPMD BOARD.

Description of Event or Problem · 0

ON (B)(6) 2016 THE CUSTOMER REPORTED BURNING SMELL/ERROR 4043 SORTER Y AXIS HOME OVERRUN WITH THEIR AIA-2000 ANALYZER. CUSTOMER REPORTED IT WOULD NOT LET THEM OPEN SORTER, THEY TURNED INSTRUMENT AND COMPUTER OFF. THE CUSTOMER IS UNABLE TO RUN BHCG FSH E2 LHII AND AFP PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING BHCG FSH E2 LHII AND AFP 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
251223	AIA-2000	AIA-2000	KHO	TOSOH CORPORATION	AIA-2000

Patients

Seq	Age	Sex	Outcome	Treatment
1