FDA Adverse Event Malfunction Summary report: N

ADVIA 1800

MDR report key: 3810363 · Received May 14, 2014

Report

Report Number: 2432235-2014-00329
Event Type: Malfunction
Date Received: May 14, 2014
Date of Event: April 15, 2014
Report Date: April 17, 2014
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC.
Product Code: JJE
PMA / PMN Number: K990346
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT DATA, THE CSE CHECKED THE INSTRUMENT HYDRAULICS, VALVES, CONNECTORS, LIQUID LEVEL SENSING, AND ALIGNMENTS, INCLUDING THE ALIGNMENT OF THE DILUTION PROBE TO THE INTERFACE GATE. THE CSE ALSO REPLACED ALL O-RINGS. DURING THE TROUBLESHOOTING, THE CSE DISCOVERED THAT GEL WAS PRESENT IN THE SAMPLE WHICH CONTAMINATED THE INSTRUMENT LINES. DECONTAMINATION AND CLEANING PROCEDURES WERE RUN THROUGH THE LINES, AFTER WHICH THERE WERE NO DISCORDANT RESULTS. THE CAUSE OF THE DISCORDANT RESULTS WAS CONTAMINATION DUE TO THE PRESENCE OF GEL IN THE SAMPLE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Description of Event or Problem · 1

THE OPERATOR OF AN ADVIA 1800 INSTRUMENT OBSERVED DISCORDANT RESULTS ON A PATIENT SAMPLE TESTED FOR MULTIPLE ASSAYS INCLUDING CREATININE, SODIUM, POTASSIUM, DIRECT BILIRUBIN, TOTAL BILIRUBIN. SOME OF THE ASSAYS RESULTED AS 'ZERO.' IT IS UNKNOWN IF ANY RESULTS WERE REPORTED TO THE PHYSICIAN(S) OR IF THE SAMPLE WAS REPEATED AND THE DISCORDANT RESULTS CORRECTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
288832	ADVIA 1800	CLINICAL CHEMISTRY ANALYZER	JJE	SIEMENS HEALTHCARE DIAGNOSTICS INC.	ADVIA 1800

Patients

Seq	Age	Sex	Outcome	Treatment
1