FDA Adverse Event Malfunction Summary report: N

TOSOH HLC-723G8 ANALYZER G8

MDR report key: 7358570 · Received March 21, 2018

Report

Report Number: 8031673-2018-03612
Event Type: Malfunction
Date Received: March 21, 2018
Date of Event: April 6, 2016
Report Date: March 21, 2018
Manufacturer: TOSOH CORPORATION
Product Code: LCP
PMA / PMN Number: K071132
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, 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. FSE WAS DISPATCHED AND ON 7-APR-2016 PERFORMED PM (PREVENTIVE MAINTENANCE) ACCORDING TO CHECKLIST. UPGRADED TO VER 5.23 AND ENABLED BARCODE OPTION M. RAN QC (QUALITY CONTROL). PERFORMED A PRECISION RUN X10. QC WITHIN LABORATORY RANGES. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS DUE TO POSTPONED PREVENTIVE MAINTENANCE.

Description of Event or Problem · 0

ON (B)(6) 2016 THE CUSTOMER REPORTED RECEIVING THE PREVENTIVE MAINTENANCE FLAG FOR SEVERAL WEEKS WITH THEIR HLC-723G8 ANALYZER. CUSTOMER REPORTED THAT THEY HAVE REPLACED THE SAMPLE NEEDLE TWICE RECENTLY POSSIBLY BECAUSE OF RECENT Z1 AXIS ERRORS. THE CUSTOMER IS UNABLE TO RUN HBA1C 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
201236	TOSOH HLC-723G8 ANALYZER G8	G8	LCP	TOSOH CORPORATION	G8

Patients

Seq	Age	Sex	Outcome	Treatment
1