FDA Adverse Event Malfunction Summary report: N

DIMENSION VISTA 1500

MDR report key: 3760190 · Received April 18, 2014

Report

Report Number: 1226181-2014-00216
Event Type: Malfunction
Date Received: April 18, 2014
Date of Event: March 26, 2014
Report Date: March 26, 2014
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS
Product Code: JGS
PMA / PMN Number: K051087
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT AND INSTRUMENT DATA EVALUATION. AFTER EVALUATION, THE CSE DETERMINED THAT THE INSTRUMENT DISPLAYED ALIQUOT AND INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PROBE ERRORS DURING THE TIME OF THE EVENT. THE DATA SUGGESTED THAT THE IMT DILUTION OF THE TWO SAMPLES WERE IMPACTED BY POOR SAMPLE QUALITY. THE CSE INSTRUCTED THE CUSTOMER TO FOLLOW THE PROPER PRE-ANALYTICAL SAMPLE HANDLING PROCEDURES AS PER THE TUBE MANUFACTURERS INSTRUCTIONS FOR USE. THE CAUSE OF THE DISCORDANT SODIUM, POTASSIUM AND CHLORIDE RESULTS IS UNKNOWN. THE CUSTOMER SUCCESSFULLY RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

Description of Event or Problem · 1

DISCORDANT SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. THE REPEATED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA, K AND CL RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
237547	DIMENSION VISTA 1500	CLINICAL CHEMISTRY SYSTEM	JGS	SIEMENS HEALTHCARE DIAGNOSTICS	DIMENSION VISTA 1500

Patients

Seq	Age	Sex	Outcome	Treatment
1