FDA Adverse Event Malfunction Summary report: N

AIA-600II

MDR report key: 7431286 · Received April 13, 2018

Report

Report Number: 8031673-2018-03043
Event Type: Malfunction
Date Received: April 13, 2018
Date of Event: December 5, 2016
Report Date: April 13, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

ON 05-12-2016, AN FSE CONDUCTED FOLLOW-UP WITH THE CUSTOMER OVER-THE-PHONE TO ADDRESS THE REPORTED EVENT. THE FSE PERFORMED TROUBLESHOOTING WITH THE CUSTOMER INSTRUCTED THE CUSTOMER TO CLEAN THE INCUBATOR. THIS ENABLED THE CUSTOMER TO REMOVE THE SAMPLE DILUTING CUP THAT WAS STUCK UNDER THE INCUBATOR AND RETURNED THE INSTRUMENT TO NORMAL OPERATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO SPILLAGE IN THE INCUBATOR AREA. 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) 2016, A CUSTOMER REPORTED A ROTOR ERROR WITH THEIR AIA-600II ANALYZER. THE CUSTOMER IS UNABLE TO RUN PROG, PRL, BHCG AND E2 PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH RESULTED IN DELAYED REPORTING PROG, PRL, BHCG AND E2 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
272255	AIA-600II	AIA-600II	KHO	TOSOH CORPORATION	AIA-600II

Patients

Seq	Age	Sex	Outcome	Treatment
1