MAUDE Adverse Event Report: CELLAVISION AB AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60; CELLAVISION DI-60

Model Number	DI-60
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60
• Common Device Name: CELLAVISION DI-60
• Manufacturer (Section D): CELLAVISION AB; mobilvägen 12; lund, se 22362 ; SW 22362
• MDR Report Key: 18989647
• Report Number: 1000515253-2024-00004
• Device Sequence Number: 11479984
• Product Code: JOY
• UDI-Device Identifier: 07350040972021
• UDI-Public: 07350040972021
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2024
• Report Date (Section F): 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DI-60
• Device Catalogue Number: CC286297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/28/2024
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/27/2024