FDA Adverse Event Malfunction Summary report: N

ADVIA AUTOSLIDE SYSTEM

MDR report key: 3811782 · Received May 15, 2014

Report

Report Number: 2432235-2014-00328
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 15, 2014
Report Date: April 20, 2014
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Product Code: GKZ
PMA / PMN Number: K051693
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) INVESTIGATED THE REPORTED MISMATCH BETWEEN THE ANALYZER RESULTS AND THE SLIDE PRODUCED BY THE ADVIA AUTOSLIDE SYSTEM. SIEMENS COULD NOT CONFIRM THE CUSTOMER'S COMPLAINT. THE CAUSE OF THIS EVENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED SIEMENS HEALTHCARE DIAGNOSTICS AND INDICATED THAT THE RESULTS FOR TWO SUCCESSIVE BLOOD SAMPLES APPEAR TO BE MISMATCHED WHEN COMPARING THE SYSTEM GENERATED DIFFERENTIAL RESULT AND THE MANUAL DIFFERENTIAL COUNT FROM THE ADVIA AUTOSLIDE SYSTEM. THE RESULTS WERE NOT REPORTED TO A PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED SAMPLE AND SLIDE MISMATCH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
289374	ADVIA AUTOSLIDE SYSTEM	ADVIA AUTOSLIDE SYSTEM	GKZ	SIEMENS HEALTHCARE DIAGNOSTICS INC.	ADVIA AUTOSLIDE SYSTEM

Patients

Seq	Age	Sex	Outcome	Treatment
1