POWERCEL POWER PROCESSOR
Received Oct 27, 2010 · Event occurred Sep 1, 2010
Report 2050012-2010-01077 · MDR key 1884347
Device
Generic name
Sample Processing System
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
A36587
Lot number
NA
Product problems
- False Positive Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER IS USING SST II PLASTIC TUBES. THE SAMPLES WERE SPUN AT 1960G FOR 10 MINUTES. NO INFORMATION REGARDING PATIENTS AND THE SYSTEM WAS PROVIDED. SERVICE INFORMATION WAS REQUESTED, BUT WAS NOT SUPPLIED. THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INCREASED NUMBER OF FALSE POSITIVE HEPATITIS B VIRUS SURFACE ANTIGEN (HBSAG) RESULTS OBTAINED FROM UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER AFTER HAVING THE ANALYZER CONNECTED TO POWERCEL POWER PROCESSOR. NO PATIENT TREATMENT WAS AFFECTED BECAUSE ALL POSITIVE RESULTS WERE RUN ON CONFIRMATORY TESTS.