FDA Adverse Event Malfunction Summary report: N

TOSOH HLC-723G8 ANALYZER

MDR report key: 7340009 · Received March 14, 2018

Report

Report Number: 8031673-2018-01686
Event Type: Malfunction
Date Received: March 14, 2018
Date of Event: July 21, 2016
Report Date: March 14, 2018
Manufacturer: TOSOH CORPORATION
Product Code: LCP
PMA / PMN Number: K071132
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

A FIELD SERVICE ENGINEER WAS DISPATCHED ON (B)(6) 2016. THE FSE INSPECTED THE LOADER, BLASTED CANNED AIR THROUGH LOADER, LUBRICATED ROLLER FOR RACK RETENTION ARM AND LEVELED OUT THE LOADER. THE FSE PERFORMED A RACK ROTATION TEST AND RAN A FULL RACK WITH SAMPLE TUBES THROUGH WITH NO ISSUES. THE OPERATOR RAN RACKS THROUGH WITH SAMPLES WITH NO ISSUES. THE SOFTWARE UPDATED FROM 5.20 TO 5.23. OPTION M HAS BEEN ENABLED (T116 (E)). THERE WAS NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. THE MOST PROBABLE CAUSE OF THE REPORTED EVENT WAS THE SAMPLE RACK, THE RETENTION BEARING NEEDED LUBRICATION. 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-(B)(4).

Description of Event or Problem · 0

ON (B)(6) 2016 A CUSTOMER REPORTED AN X1 AXIS ERROR WITH THEIR G8 ANALYZER. THE CUSTOMER IS UNABLE TO 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
181500	TOSOH HLC-723G8 ANALYZER	G8	LCP	TOSOH CORPORATION	G8

Patients

Seq	Age	Sex	Outcome	Treatment
1