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ADVIA 120

Received Nov 4, 2005 · Event occurred Sep 28, 2005

Report 2432235-2005-00017 · MDR key 645154

Device

Generic name

Hematology System

Model number

ADVIA 120

Catalog number

*

Lot number

*

Product problems

  • Method, improper/incorrect
  • Incorrect Or Inadequate Test Results

Patient

42 YR

  • Transfusion of blood products

Narrative

Description of Event or Problem

IN 2005 A LAB SUPERVISOR AT A HOSP NOTIFIED BAYER THAT A RESULT FOR A PT'S PLATELET LEVEL OF 16,000/MM3 HAD BEEN REPORTED. THE LABORATORY STATED THAT ONE WEEK LATER A SAMPLE WAS DRAWN FROM THE PT AND AN INITIAL COUNT OF 16,000 PLATELETS WAS OBTAINED ON AN ADVIA 120 HEMATOLOGY ANALYZER. A SMEAR OF THE SAMPLE WAS CREATED AND A VISUAL COUNT WAS DONE THAT PRODUCED THE SAME RESULTS. FURTHER, A VISUAL EXAMINATION OF THE SAMPLE REVEALED THAT THERE WAS NO EVIDENCE OF CLOTS. A SECOND DRAW OF THE PT WAS DONE. THE LABORATORY REPORTED A COUNT OF 260,000 PLATELETS ON THE SECOND DRAW, WHICH WAS CONFIRMED ON VISUAL EXAMINATION. THIS REVISED COUNT WAS THEN REPORTED. THE PT HAD ALREADY BEEN TRANSFUSED WITH PLATELETS AT THAT TIME. A SECOND VISUAL REVIEW OF THE FIRST SAMPLE IT WAS DETERMINED THAT THERE WAS A CLOT IN THE SAMPLE THAT HAD NOT BEEN OBSERVED INITIALLY ON THE SMEAR. STANDARD GOOD LABORATORY PRACTICE REQUIRES THAT OPERATORS PRESENTED WITH LOW PLATELET COUNTS RETURN THE SAMPLE AND/OR CHECK THE SAMPLE FOR CLOTS. IN THE INSTANCES CITED FOR THIS EVENT, THE ADVIA 120 RESULT AND THE MANUAL PLATELET COUNT PRODUCED SIMILAR RESULTS. IMPROPER PRE-ANALYTICAL HANDLING OF THE SPECIMEN IS THE SUSPECTED CAUSE FOR THE PLATELET COUNT DISCREPANCY.