FDA Adverse Event Malfunction Summary report: N

DIMENSION VISTA 500

MDR report key: 3123472 · Received May 21, 2013

Report

Report Number: 1226181-2013-00236
Event Type: Malfunction
Date Received: May 21, 2013
Date of Event: April 19, 2013
Report Date: April 25, 2013
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC
Product Code: JJE
PMA / PMN Number: K051087
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE DISCORDANT CA AND TSH RESULTS WERE CAUSED BY A SAMPLE INTEGRITY ISSUE: USER ERROR. THE TSC VERIFIED THAT THE TSH LEVEL 3 QC WAS OUT AT THE TIME OF THE ORIGINAL RUN AND THAT THE DATA INDICATED THAT FIBRIN WAS PULLED FROM THE PRIMARY SAMPLE TUBE, LEADING TO AN ELEVATED RESULT. THE LOW CA RESULT WAS ATTRIBUTED TO A SHORT SAMPLE / LOW SAMPLE RECOVERY. THE TSC VERIFIED THAT THERE WERE NO INSTRUMENT PERFORMANCE ISSUES DURING THE TIME OF THE EVENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

Description of Event or Problem · 1

DISCORDANT CALCIUM (CA) AND THYROID STIMULATING HORMONE (TSH) RESULTS WERE OBTAINED ON A DIMENSION VISTA 500 INSTRUMENT FOR ONE PATIENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THE PHYSICIAN REQUESTED THE PATIENT BE RETESTED AT ANOTHER FACILITY. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM AND TSH RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
224068	DIMENSION VISTA 500	CLINICAL CHEMISTRY ANALYZER	JJE	SIEMENS HEALTHCARE DIAGNOSTICS INC	DIMENSION VISTA 500

Patients

Seq	Age	Sex	Outcome	Treatment
1