MalfunctionCEO
C8000 PHOSPHORUS
Received Jul 24, 2007 · Event occurred Oct 9, 2006
Report 2018433-2007-00043 · MDR key 884216
Device
Generic name
Quantitation Of Phosphorus In Human Serum, Plasma Or Urine
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
7D71-20
Lot number
42020HW00
Product problems
- Unknown (for use when the device problem is not known)
Patient
NI YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATES THAT 3-4 PATIENT SAMPLES THAT GENERATED PHOSPHORUS RESULTS >15 MG/DL, QUESTIONED BY A PHYSICIAN AND WHEN REPEATED AFTER CALIBRATING THE ARCHITECT C8000 PROCESS MODULE, THE RESULTS WERE NORMAL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Remedial action
- Other