FDA Adverse Event Malfunction Summary report: N

IMMULITE 2000 XPI

MDR report key: 3884650 · Received June 19, 2014

Report

Report Number: 2247117-2014-00035
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: May 27, 2014
Report Date: May 28, 2014
Manufacturer: SIEMENS HEALTCHCARE DIAGNOSTICS INC
Product Code: JJQ
PMA / PMN Number: P010053/S007
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE CUSTOMER STATED THAT WATER WAS NOT PRIMING THROUGH THE WATERLINE WHEN PERFORMING THE DAILY MAINTENANCE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DISCOVERED THAT THE LINEAR ACTUATOR WATER PUMP HAD FAILED. THE CSE REPLACED THE WATER PUMP AND RAN QUALITY CONTROLS, WHICH RESULTED WITHIN RANGE. THE CAUSE OF THE DISCORDANT RESULTS IS A WATER PUMP FAILURE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

DISCORDANT RESULTS WERE OBTAINED ON PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULTS WERE RELEASED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AFTER SERVICE WAS PERFORMED AND CORRECTED RESULTS WERE OBTAINED AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360510	IMMULITE 2000 XPI	IMMULITE 2000 XPI	JJQ	SIEMENS HEALTCHCARE DIAGNOSTICS INC	IMMULITE 2000 XPI

Patients

Seq	Age	Sex	Outcome	Treatment
1