FDA Adverse Event Malfunction Summary report: N

DIMENSION VISTA 1500

MDR report key: 3230040 · Received July 16, 2013

Report

Report Number: 1226181-2013-00310
Event Type: Malfunction
Date Received: July 16, 2013
Date of Event: June 15, 2013
Report Date: June 19, 2013
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC
Product Code: JGS
PMA / PMN Number: K051087
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST RECOMMENDED TO SWITCH TO A NEW SENSOR LOT . THE CUSTOMER REPEATED THE SAMPLE ON THE SAME INSTRUMENT AND THE SAMPLE RESULTED AS EXPECTED UPON REPEAT TESTING. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED SODIUM AND POTASSIUM RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

DISCORDANT, FALSELY ELEVATED SODIUM AND POTASSIUM RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS FLAGGED BY THE SYSTEM'S DELTA CHECK AS IT DID NOT MATCH RESULTS PREVIOUSLY OBTAINED ON SAMPLES FROM THE PATIENT. THE SAMPLE WAS REPEATED ONCE FROM THE SAME ALIQUOT AND ONCE FROM THE ORIGINAL TUBE ON THE SAME INSTRUMENT AND BOTH SODIUM AND POTASSIUM RESULTED LOWER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED SODIUM AND POTASSIUM RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
328686	DIMENSION VISTA 1500	CLINICAL CHEMISTRY ANALYZER	JGS	SIEMENS HEALTHCARE DIAGNOSTICS INC	DIMENSION VISTA 1500

Patients

Seq	Age	Sex	Outcome	Treatment
1