FDA Adverse Event Malfunction Summary report: N

ADVIA 1800

MDR report key: 3131853 · Received May 29, 2013

Report

Report Number: 2432235-2013-00194
Event Type: Malfunction
Date Received: May 29, 2013
Date of Event: April 18, 2013
Report Date: May 2, 2013
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Product Code: PDJ
PMA / PMN Number: K990346
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS TECHNICAL APPLICATIONS SPECIALIST (TAS) VISITED THE CUSTOMER SITE. THE CUSTOMER AND THE TAS PERFORMED TWO HBA1C COMPARISON STUDIES BETWEEN THE ADVIA 1800 INSTRUMENT AND THE ALTERNATE INSTRUMENT. THE DIFFERENCE BETWEEN THE MEAN OF THE PATIENT SAMPLES ON THE ADVIA 1800 AND THE MEAN OF THE PATIENT SAMPLES ON THE ALTERNATE INSTRUMENT WERE WITHIN THE EXPECTED RANGES STATED IN THE ADVIA CHEMISTRY INSTRUCTIONS FOR USE FOR HBA1C. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED HBA1C RESULT ON ONE PATIENT SAMPLE WAS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

A DISCORDANT, FALSELY ELEVATED HEMOGLOBIN A1C (HBA1C) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. TWO SAMPLES WERE OBTAINED FROM THE PATIENT; ONE SAMPLE WAS TESTED ON AN ADVIA 1800 AND THE OTHER SAMPLE WAS TESTED ON AN ALTERNATE SYSTEM. A HIGHER RESULT WAS OBTAINED ON THE ADVIA 1800 INSTRUMENT. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE DIFFERENCE IN THE RESULTS. IT IS UNKNOWN IF THE SAMPLE WAS RERUN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED HBA1C RESULT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
235125	ADVIA 1800	CLINICAL CHEMISTRY ANALYZER	PDJ	SIEMENS HEALTHCARE DIAGNOSTICS INC.	ADVIA 1800

Patients

Seq	Age	Sex	Outcome	Treatment
1