InjuryJOY

AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60

Received Mar 27, 2024 · Event occurred Sep 10, 2023

Report 1000515253-2024-00004 · MDR key 18989647

Device

Generic name

Cellavision Di-60

Manufacturer

Cellavision Ab

Model number

DI-60

Catalog number

CC286297

Product problems

Use of Device Problem
Use of Device Problem

Patient

72 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE USER REPORTED THAT AUER RODS WERE REPORTED FROM THE DI-60 CELLAVISION IN ERROR. PER THE USER, AN OPERATOR SELECTED AN INCORRECT CELL CATEGORY. DUE TO THE ERRONEOUS RESULTS REPORTED, A PATIENT UNDERWENT AN UNNECESSARY BONE MARROW ASPIRATION. NO HARM WAS REPORTED DUE TO THE UNNECESSARY BONE MARROW PROCEDURE.