MalfunctionCEP
ARCHITECT INSULIN
Received Apr 29, 2008
Report 1415939-2008-00058 · MDR key 1036116
Device
Generic name
Cmia Quantitation Of Human Insulin
Manufacturer
Abbott LaboratoriesModel number
NACatalog number
8K41-26
Lot number
58020LP17
Product problems
- Low Test Results
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED THAT AN INITIAL ARCHITECT INSULIN RESULT OF 80 UU/ML WAS GENERATED. THE SAMPLE WAS REPEATED AND RESULTS OF 149 UU/ML AND 150 UU/ML WERE GENERATED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.