ADVIA 120
Received Mar 2, 2004 · Event occurred Jan 25, 2004
Report 2432235-2004-00003 · MDR key 531074
Device
Generic name
Hematology System
Manufacturer
Bayer Diagnostics Mfg. Ltd.Model number
ADVIA 120Catalog number
*
Lot number
*
Product problems
- Incorrect Or Inadequate Test Results
Patient
89 YR
- Transfusion of blood products
Narrative
Description of Event or Problem
IN 2/2004 A BAYER TECHNICAL SERVICE SPECIALIST REPORTED THAT A CUSTOMER HAD SENT OUT AN ERRONEOUS RESULT FOR A PT'S HEMOGLOBIN LEVEL THAT LED TO THE PT BEING TRANSFUSED. THE HOSP CLAIMS THAT A CBC DIFFERENTIAL WAS RUN ON THE ADVIA 120 INSTRUMENT, AN INITIAL RESULT FOR HEMOGLOBIN OF 8.4 G/DL WAS REPORTED. THE RESULTS FOR SOME WHITE BLOOD CELL (WBC) PARAMETERS FOR THIS SAMPLE WERE CLEARLY FLAGGED, BUT NO RED BLOOD CELL PARAMETERS WERE FLAGGED SO THOSE RESULTS WERE REPORTED. THE LAB REPORTED THAT THEY DID NOT REPEAT TESTING ON THE SAMPLE EVEN THOUGH IT FLAGGED WHITE BLOOD CELL COUNTS BECAUSE IT IS THEIR PRACTICE TO VERIFY THE WBC COUNT WITH A SMEAR COUNT. QUALITY CONTROLS WERE WITHIN SPECIFICATIONS. THE PT WAS TRANSFUSED WITH TWO UNITS OF BLOOD BASED ON THE 8.4 G/DL HEMOGLOBIN COUNT. A POST-TRANSFUSION SAMPLE GAVE A RESULT OF 16.0 G/DL. THE LAB RERAN THE PRETRANSFUSION SAMPLE AND THE HEMOGLOBIN RESULT WAS 11.5 G/DL. AT THIS TIME ERRORS ASSOCIATED WITH SAMPLE COLLECTION, HANDLING AND MIXING CANNOT BE RULED OUT. IT IS UNKNOWN WHAT CAUSED THE EVENT BUT THE CUSTOMER FEELS SATISFIED THAT THE SYSTEM IS OPERATING AS SPECIFIED.