FDA Adverse Event Malfunction Summary report: N

UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

MDR report key: 1873162 · Received October 18, 2010

Report

Report Number: 2050012-2010-00991
Event Type: Malfunction
Date Received: October 18, 2010
Date of Event: September 24, 2010
Report Date: October 18, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: JJE
PMA / PMN Number: K042291
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THERE WAS NO INDICATION OF CALIBRATION OR QC PROBLEMS PRIOR TO THE EVENT. THE CUSTOMER INDICATED THEIR ACCEPTANCE CRITERIA FOR DUPLICATE TESTING IS WITHIN 10%. IF NOT, THE SAMPLE IS RUN AND CONFIRMED BY AN ALTERNATE METHOD. A BCI FIELD SERVICE ENGINEER (FSE) INSTALLED AND REBUILT A GLUCOSE MODULE ON (B)(6) 2010 PRIOR TO THE EVENT. THE FSE RETURNED ON (B)(6) 2010 AFTER THE EVENT AND REPLACED THE STIRRER MOTOR. THE PRECISION RUNS AND QC RESULTS WERE WITHIN ESTABLISHED SPECIFICATIONS AFTER THE STIRRER MOTOR WAS REPLACED. BCI REQUESTED THE REPLACED STIRRER MOTOR TO BE RETURNED FOR INVESTIGATION. A ROOT CAUSE FOR THIS EVENT APPEARS TO BE HARDWARE, THE STIRRER MOTOR.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW DUPLICATE GLUCOSE (GLUCM) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM FOR EIGHT TO TEN PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE TESTED BY ANOTHER METHOD FOR CONFIRMATION. THE CUSTOMER STATED THE SAMPLE RESULTS WERE IN THE RANGE OF 80 TO 100 MG/DL. THE SPECIFIC RESULTS WERE NOT PROVIDED. THERE WAS NO EFFECT TO PATIENT OR USER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM	CLINICAL CHEMSTRY ANALYZER	JJE	BECKMAN COULTER, INC.	DXC 800 PRO	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1