FDA Adverse Event Malfunction Summary report: N

DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

MDR report key: 2747642 · Received September 17, 2012

Report

Report Number: 2517506-2012-00222
Event Type: Malfunction
Date Received: September 17, 2012
Date of Event: July 24, 2012
Report Date: August 22, 2012
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Product Code: JFY
PMA / PMN Number: K090330
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE IMPRECISE CREATININE RESULTS IS USER ERROR. THE ACCOUNT SET THE DIGITS OF PRECISION SETTING TO ONE (1) WHICH PROVIDED RESULTS IN A ONE DIGIT OF PRECISION VALUE ONLY. THE LOW SETTING OF DIGITS OF PRECISION CAUSE RESULTS TO BE ROUNDED WITH RESULTING IMPRECISION AT LOW ANALYTE AND HIGH ANALYTE VALUES. THE SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL SERVICE CENTER REPRESENTATIVE INSTRUCTED THE ACCOUNT TO CORRECT THE DIGITS OF PRECISION SETTING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

A GROUP OF IMPRECISE CREATININE RESULTS WAS OBTAINED ON PATIENT AND QC SAMPLES. RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. RESULTS WERE REPORTED TO ONLY ONE DIGIT OF PRECISION. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED AS A RESULT OF THE IMPRECISE CREATININE RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE IMPRECISE CREATININE RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM	ENZYMATIC CREATININE FLEX® REAGENT CARTRIDGE	JFY	SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW		12100AE

Patients

Seq	Age	Sex	Outcome	Treatment
1