FDA Adverse Event Malfunction Summary report: N

TOSOH HLC-723G8 ANALYZER

MDR report key: 7449390 · Received April 21, 2018

Report

Report Number: 8031673-2018-05207
Event Type: Malfunction
Date Received: April 21, 2018
Date of Event: August 25, 2015
Report Date: April 21, 2018
Manufacturer: TOSOH CORPORATION
Product Code: LCP
PMA / PMN Number: K071132
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

A FIELD SERVICE ENGINEER WAS DISPATCHED ON 8/25/2015. THE FSE REPLACED SAMPLE LOOP. ADJUSTED DETECTOR OUTPUT TO NEAR 0MV. CALIBRATED AND RAN TOSOH QC (QUALITY CONTROL) LOT 7030 WITH L-1 AND L-2 VALUES READING CLOSE TO TARGET. CUSTOMER REPEATED AND ALL QC WAS WITHIN SPECIFICATIONS NO FURTHER ACTIONS WERE REQUIRED BY FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT THE SAMPLING LOOP CAUSED A HIGH QC. 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) 2015 A CUSTOMER REPORTED QUALITY CONTROLS RECOVERY ISSUES WITH THEIR G8 ANALYZER. THE CUSTOMER WAS UNABLE TO RUN HBGA1C PATIENT SAMPLES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT,WHICH RESULTED IN DELAYED REPORTING HBA1C 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
292163	TOSOH HLC-723G8 ANALYZER	G8	LCP	TOSOH CORPORATION	G8

Patients

Seq	Age	Sex	Outcome	Treatment
1