FDA Adverse Event Malfunction Summary report: N

TOSOH HLC-723GA ANALYZER G8

MDR report key: 7345348 · Received March 16, 2018

Report

Report Number: 8031673-2018-03140
Event Type: Malfunction
Date Received: March 16, 2018
Date of Event: April 27, 2016
Report Date: March 16, 2018
Manufacturer: TOSOH CORPORATION
Product Code: LCP
PMA / PMN Number: K071132
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, 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 28-APRI;-2016, THE FSE ARRIVED AT THE SITE TO ADDRESS THE REPORTED EVENT. UPON ARRIVAL, INSPECTION OF THE DEVICE REVEALED THAT THE HEMOLYSIS WASH LINE WAS FUNCTIONING PROPERLY. THE FSE UPDATED THE DEVICE SOFTWARE AND SAMPLES AND CHROMATOGRAMS RAN WITHOUT ISSUE. NO FURTHER ACTION WAS REQUIRED BY FSE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE FAULT/FAILURE OF THE HEMOLYSIS LINE.

Description of Event or Problem · 0

ON (B)(6) 2016, THE CUSTOMER REPORTED NO PEAKS AND NO TOTAL AREA WITH THE G8 ANALYZER. THE CUSTOMER CHANGED THE NEEDLE WITH NO RESOLUTION. CHROMATOGRAMS WERE FAXED TO TECHNICAL SUPPORT (TS) FOR REVIEW. 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
189702	TOSOH HLC-723GA ANALYZER G8	G8	LCP	TOSOH CORPORATION	G8

Patients

Seq	Age	Sex	Outcome	Treatment
1