FDA Adverse Event Malfunction Summary report: N

AIA-900

MDR report key: 7356471 · Received March 20, 2018

Report

Report Number: 8031673-2018-03906
Event Type: Malfunction
Date Received: March 20, 2018
Date of Event: July 21, 2015
Report Date: March 20, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE COMPLAINT WAS DISPATCHED TO THE FIELD SERVICE ENGINEER (FSE) DEPARTMENT ON THE 21ST OF JULY 2015 FOR FURTHER INVESTIGATION. THE FSE CONDUCTED A FOLLOW-UP WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. DURING THE INVESTIGATION THE FSE WAS INFORMED THAT FOLATE IS RECEIVING HIGH RESULT >20 RATHER THAN THE ACTUAL VALUE. FSE SUGGESTED TO THE CUSTOMER TO CONTACT TECHNICAL SUPPORT TO DISCUSS PARAMETER SETTING. ON A FOLLOWUP CALL WITH THE CUSTOMER THEY INDICATED THAT A RESOLUTION TO THE REPORTED PROBLEM HAS BEEN FOUND AND PATIENTS SAMPLES HAVE RAN WITHOUT ANY PROBLEMS OR HIGH RECOVERED VALUES. INSTRUMENT IS FUNCTIONING AS INTENDED AND WAS RELEASED. THE PROBABLE CAUSE OF THE EVENT WAS PARAMETER SETTING. 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 THE (B)(6) 2015 A CUSTOMER REPORTED FAILING PROFICIENCY TESTING FOR FOLATE ON THEIR AIA-900 AND HAS CONCERNS WITH PATIENTS RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
195158	AIA-900	AIA-900	KHO	TOSOH CORPORATION	AIA-900

Patients

Seq	Age	Sex	Outcome	Treatment
1