FDA Adverse Event Malfunction Summary report: N

DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

MDR report key: 3820097 · Received May 20, 2014

Report

Report Number: 1226181-2014-00283
Event Type: Malfunction
Date Received: May 20, 2014
Date of Event: April 29, 2014
Report Date: April 29, 2014
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Product Code: JJE
PMA / PMN Number: K051087
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). DURING TROUBLESHOOTING, THE CCC SPECIALIST LEARNED THAT THERE WERE NO OTHER DISCORDANT RESULTS ON OTHER PATIENT SAMPLES. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA, WHICH INDICATED THAT NOT ENOUGH SAMPLE HAD BEEN ASPIRATED FOR THE TEST. THE HSC SPECIALIST MADE RECOMMENDATIONS FOR SAMPLE HANDLING TO PREVENT SAMPLES FROM CONTAINING CELLULAR MATERIAL OR MICRO CLOTS, WHICH CAN IMPACT SAMPLE ASPIRATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem · 1

A DISCORDANT, FALSELY LOW TOTAL BILIRUBIN (TBIL) RESULT WAS OBTAINED ON ONE NEONATAL PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT AND RESULTED HIGHER. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW TBIL RESULT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
300061	DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM	CLINICAL CHEMISTRY ANALYZER	JJE	SIEMENS HEALTHCARE DIAGNOSTICS INC.	DIMENSION VISTA 500

Patients

Seq	Age	Sex	Outcome	Treatment
1