FDA Adverse Event Malfunction Summary report: N

ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

MDR report key: 4734892 · Received April 28, 2015

Report

Report Number: 2432235-2015-00216
Event Type: Malfunction
Date Received: April 28, 2015
Date of Event: April 6, 2015
Report Date: April 6, 2015
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Product Code: GKZ
PMA / PMN Number: K102644
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS HEALTHCARE DIAGNOSTICS INC. FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AND FOUND BUBBLES AT THE COMPRESSOR OF THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT. HE REPLACED THE REAGENT DIAPHRAGM PUMP ASSEMBLY, CLEANED THE VACUUM AND PRESSURE LINES AND RAN QUALITY CONTROL MATERIAL. ALL GRAPHS, CYTOGRAMS AND QUALITY CONTROL MATERIAL WERE NORMAL AND WITHIN PERFORMANCE RANGES. THE CAUSE OF THE EVENT IS A FAILED REAGENT DIAPHRAGM PUMP ASSEMBLY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem · 1

A SIEMENS HEALTHCARE DIAGNOSTICS INC. PRODUCT SPECIALIST REPORTED THAT AN ABNORMAL COMPLETE BLOOD COUNT (CBC) RESULT WAS PRODUCED BY THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER INSTRUMENT AT A CUSTOMER SITE. THE ABNORMAL CBC RESULT WAS DUE TO BUBBLES AND LIQUID LEAKING FROM THE COMPRESSOR AND DRIPPING OVER THE POWER SOCKET OF THE INSTRUMENT. NO PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN. QUALITY CONTROL DATA NOR PATIENT RESULTS WERE AVAILABLE FOR ASSESSMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ABNORMAL CBC RESULT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
279647	ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER	ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER	GKZ	SIEMENS HEALTHCARE DIAGNOSTICS INC.	ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

Patients

Seq	Age	Sex	Outcome	Treatment
1