MalfunctionCEO
C8000 PHOSPHORUS
Received Jul 24, 2007 · Event occurred Jun 15, 2007
Report 2018433-2007-00046 · MDR key 884213
Device
Generic name
Quantitation Of Phosphorus In Human Serum, Plasma Or Urine
Manufacturer
Abbott Manufacturing, Inc.Model number
NACatalog number
7D71-20
Lot number
UNK
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 STATED THAT AFTER CHANGING THE PHOSPHORUS REAGENT, RUN ON THE ARCHITECT C8000 ANALYZER, THE CONTROL VALUES ARE 0.0 MG/DL BEFORE AND AFTER CALIBRATING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Remedial action
- Other