MalfunctionCEO
PHOSPHORUS
Received Jul 23, 2007 · Event occurred Dec 19, 2007
Report 2018433-2007-00039 · MDR key 883528
Device
Generic name
Quantitation Of Phosphorus In Human Serum, Plasma, Or Urine
Manufacturer
Abbott Manufacturing, IncModel number
NACatalog number
7D71-30
Lot number
42020HW00
Product problems
- Unknown (for use when the device problem is not known)
Patient
NI
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER STATED THAT THE URINE PHOSPHORUS CONTROL VALUES, RUN ON THE AEROSET ANALYZER, HAVE BEEN RUNNING LOW ON THE PHOSPHORUS REAGENT LOT#42020HW00. THE CUSTOMER STATED THAT A NEW REAGENT, SAME LOT, WAS USED AND THE CONTROL VALUES WERE IN RANGE. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.
Remedial action
- Other