SYNCHRON LX®20 PRO CLINICAL CHEMISTRY SYSTEM

MDR report key: 2172780 · Received July 22, 2011

Report

Report Number: 2050012-2011-03086
Event Type: Malfunction
Date Received: July 22, 2011
Date of Event: June 17, 2011
Report Date: June 17, 2011
Manufacturer: BECKMAN COULTER, INC.
Product Code: JJE
PMA / PMN Number: K011213
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ERRONEOUS DATA GENERATED.

Description of Event or Problem · 1

THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUSLY HIGH TRIGLYCERIDE (TG) RESULTS FOR TWO PATIENT SAMPLES ASSAYED WITH TRIGLYCERIDE REAGENT ON A SYNCHRON LX 20 PRO CLINICAL CHEMISTRY SYSTEM. THE HIGH TG RESULTS FOR THE TWO PATIENT SAMPLES WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THE CUSTOMER RE-ASSAYED BOTH PATIENT SAMPLES FOR TG ON ANOTHER ANALYZER IN THEIR LABORATORY AND OBTAINED LOWER RESULTS WHICH WERE INTERPRETED TO BE CORRECT. THE CUSTOMER HAD RUN QUALITY CONTROLS FOR TG PRIOR TO THE EVENT. THE BIO RAD LEVEL 2 CONTROL HAD RECOVERED HIGH WITH RESPECT TO THE LABORATORY'S ESTABLISHED RANGE. THE CUSTOMER REPEATED THE TG ASSAY FOR THE BIO RAD LEVEL 2 CONTROL WHICH YIELDED AN ACCEPTABLE RESULT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED THAT THE WASH TOWER ON THE ANALYZER WAS NOT FUNCTIONING PROPERLY. IN ADDITION, LEAKS WERE OBSERVED COMING FROM THE REAGENT PROBE A WASH COLLAR. THE FSE REPLACED THE WASH STATION AND THE REAGENT PROBE A WASH COLLAR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHRON LX®20 PRO CLINICAL CHEMISTRY SYSTEM	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	JJE	BECKMAN COULTER, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1				TRIGLYCERIDE REAGENT