FDA Adverse Event Malfunction Summary report: N

A1A-900

MDR report key: 7382519 · Received March 29, 2018

Report

Report Number: 8031673-2018-04442
Event Type: Malfunction
Date Received: March 29, 2018
Date of Event: July 17, 2017
Report Date: March 29, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE, 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 18-JUL-2017, THE FSE CLEARED A PLUG IN THE SUBSTRATE TUBING AND RAN A DAILY CHECK. THE SUBSTRATE BACKGROUND MEASUREMENT PASSED ALL SPECIFICATIONS AND THE ANALYZER RESUMED NORMAL OPERATION. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS A BLOCKED TUBE AT THE JUNCTION OF THE TUBING TO SUBSTRATE DISPENSE HEATER. THE CAUSE OF THE BLOCKAGE WAS UNKNOWN.

Description of Event or Problem · 0

ON (B)(6) 2017, THE CUSTOMER REPORTED A FAILING BACKGROUND CHECK ON THEIR AIA-900 ANALYZER. THE CUSTOMER PRIMED THE ANALYZER FIVE TIMES WITHOUT ERROR, CHANGED THE WASH PROBE TIPS, MADE NEW SUBSTRATE, AND REPEATED THE BACKGROUND CHECK WITHOUT RESOLUTION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT, WHICH MAY HAVE RESULTED IN DELAYED REPORTING OF BHCG AND HBA1C PATIENT RESULTS. THERE WAS NO INDICATION OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIAL DELAY IN REPORTING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
224688	A1A-900	A1A-900	KHO	TOSOH CORPORATION	A1A-900

Patients

Seq	Age	Sex	Outcome	Treatment
1