FDA Adverse Event Malfunction Summary report: N

AIA-2000

MDR report key: 7368512 · Received March 23, 2018

Report

Report Number: 8031673-2018-04307
Event Type: Malfunction
Date Received: March 23, 2018
Date of Event: November 8, 2016
Report Date: March 23, 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

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. ON 09-NOV-2016, AN FSE CONDUCTED ON-SITE FOLLOW-UP WITH THE CUSTOMER. THE FSE REPLACED THE COMPUTER. THE FSE REMOVED THE CPU TAG BVH6KN1, SERVICE CODE 25847917309, AND INSTALLED CPU TAG GVTP8Y1 SERVICE CODE 36752855689. THE FSE ALSO INSTALLED THE PRINTER DRIVER AND ADJUSTED THE SCREEN RESOLUTION. THE INSTRUMENT RETURNED TO NORMAL OPERATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO A DEFECTIVE COMPUTER.

Description of Event or Problem · 0

ON (B)(6) 2016, A CUSTOMER REPORTED AN UNRECOGNIZED DATABASE FORMAT WITH THEIR AIA-2000 ANALYZER. THE CUSTOMER IS UNABLE TO RUN PRL, PROG, PTH, BHCG, AFP, FSH AND LHII PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING PRL, PROG, PTH, BHCG, AFP, FSH AND LHII 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
207845	AIA-2000	AIA-2000	KHO	TOSOH CORPORATION	AIA-2000ST

Patients

Seq	Age	Sex	Outcome	Treatment
1