MalfunctionCEO
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
Received Dec 18, 2010 · Event occurred Nov 18, 2010
Report 2050012-2010-01604 · MDR key 1932490
Device
Generic name
Clinical Chemstry Analyzer
Manufacturer
Beckman Coulter, Inc.Model number
DXC800 PROCatalog number
A11812
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW PHOSPHOROUS (PHOSM) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM FOR 43 PATIENTS. FOURTEEN RESULTS WERE REPORTED OUT OF THE LABORATORY AND AMENDED BEFORE PATIENT TREATMENT WAS IMPACTED.
Additional Manufacturer Narrative
QC AND CALIBRATION RESULTS WERE ACCEPTABLE PRIOR TO THE EVENT. THE INSTRUMENT WOULD NOT CALIBRATE FOR PHOSM AFTER THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE PHOSM MODULE.
Remedial action
- Inspection
- Replace