FDA Adverse Event Malfunction Summary report: N

AIA 2000

MDR report key: 7333462 · Received March 13, 2018

Report

Report Number: 8031673-2018-02139
Event Type: Malfunction
Date Received: March 13, 2018
Date of Event: February 8, 2017
Report Date: March 13, 2018
Manufacturer: TOSOH CORPORATION
Product Code: KHO
PMA / PMN Number: K971103
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE FOR INTERVENTION/REPAIR. THEY BLEACHED THE WASH AND DILUENT LINES, AND RAN 0.1 NORMALITY HYDROCHLORIDE (0.1N HCL) THROUGH THE SUBSTRATE LINES. THE P/D TABLE TEMPERATURE WAS ADJUSTED FROM APPROXIMATELY 40 DEGREES CELSIUS TO 37 DEGREES CELSIUS. TROPONIN LOT 55 WAS RECALIBRATED AND THE QUALITY CONTROLS(QCI) WERE RAN AND WITHIN RANGE. THE AIA-2000 WAS FUNCTIONING AS INTENDED. NO FURTHER ACTION REQUIRED FROM FIELD SERVICE. THE PROBABLE CAUSE OF THE EVENT WAS FAULT OR FAILURE OF THE DETECTOR. 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) 2017 THE CUSTOMER CONTACTED TECHNICAL SUPPORT (TS) TO REPORT HIGH CONTROLS FOR LEVEL 1USING BIORAD (BR) 2320 AND TROPONIN LOT 55 AFTER RECEIVING PREVENTATIVE MAINTENANCE (PM) ON THE AIA-2000. ON (B)(6) 2017, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ADDRESS THE REPORTED EVENT OVER THE PHONE. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DELAY IN REPORTING OF PATIENT RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
177691	AIA 2000	AIA 2000	KHO	TOSOH CORPORATION	AIA-2000

Patients

Seq	Age	Sex	Outcome	Treatment
1