CELL DYN SAPPHIRE ANALYZER
Received Oct 25, 2006 · Event occurred Sep 27, 2006
Report 2919069-2006-00083 · MDR key 828654
Device
Generic name
Automated Hematology Analyzer
Manufacturer
Abbott Laboratories Division/celldynModel number
NACatalog number
8H00-01
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED CUSTOMER SUPPORT STATING THAT AN INCORRECT HEMOGLOBIN RESULT OF 5.23 MMOL/L (8.48 G/DL) WAS GENERATED USING A CELL-DYN SAPPHIRE ANALYZER AND REPORTED TO A PHYSICIAN FOR ONE FEMALE PT (AGE AND WEIGHT WERE NOT PROVIDED). THE RESULT WAS SUBJECT TO DOUBT BECAUSE OF PREVIOUS HEMOGLOBIN RESULT HISTORY FOR THIS PT AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS THEN REPEATED USING THE SAME SAMPLE YIELDING A HEMOGLOBIN RESULT OF 7.19 MMOL/L (11.65 G/DL). ANOTHER SAMPLE OBTAINED FROM THIS PT WAS TESTED YIELDING A HEMOGLOBIN RESULT OF 7.2 MMOL/L (11.69). NO IMPACT TO PT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.