FDA Adverse Event Malfunction Summary report: N

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

MDR report key: 2233856 · Received September 4, 2011

Report

Report Number: 2122870-2011-03155
Event Type: Malfunction
Date Received: September 4, 2011
Date of Event: August 4, 2011
Report Date: August 5, 2011
Manufacturer: BECKMAN COULTER INC.
Product Code: JJE
PMA / PMN Number: K023764
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE SAMPLES ARE COLLECTED IN A BD LITHIUM HEPARIN PST TUBE AND ARE CENTRIFUGED FOR 5 MINUTES AT 5000 RPM IN A SWING BUCKET CENTRIFUGE. CUSTOMER NOTED THAT THE ORIGINAL SAMPLE FROM PATIENT WAS A SHORT DRAW. THE TOTAL BHCG QC WAS WITHIN CUSTOMERS ESTABLISHED RANGES PRIOR TO THE EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ALTHOUGH SAMPLE HANDLING MAY HAVE BEEN A CONTRIBUTING FACTOR, NO ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A FALSE POSITIVE TOTAL BETA - HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT FOR ONE PATIENT WHICH DID NOT FIT THE CLINICAL PICTURE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE PHYSICIAN QUESTIONED THE ORIGINAL REPORTED RESULT. A SUBSEQUENT SAMPLE FROM THE PATIENT RESULTED WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	JJE	BECKMAN COULTER INC.	DXI 800	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR