CELL-DYN 1700
Received Feb 23, 2006 · Event occurred Jan 29, 2006
Report 2919069-2006-00012 · MDR key 680337
Device
Generic name
Automated Hematology Analyzer
Manufacturer
Abbott Diagnostics Division/celldynModel number
NACatalog number
3H53-01
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
39 YR
- Electrolyte Imbalance
- Transfusion of blood products
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A CUSTOMER TECHNICAL ADOVCATE (CTA) WAS CONTACTED WITH REGARD TO A LOW HEMOGLOBIN RESULT GENERATED WHEN USING A CELL-DYN 1700 ANALYZER. IN 2006 A PATIENT WITH A HGB=5.0 G/DL WAS TRANSFUSED WITH 3 UNITS OF BLOOD. THE FOLLOWING DAY A HGB=7.9 G/DL WAS OBTAINED. THE FOLLOWING DAY A NEW SAMPLE WAS DRAWN AND A HGB=6.1 G/DL WAS OBTAINED WHICH WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS REDRAWN AND A SAMPLE SENT OT A REFERENCE LAB OBTAINING DUPLICATE RESULTS OF HGB=9.0 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.