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	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user alleged the patient received seven unnecessary platelet (plt) transfusions over several days and one bone marrow procedure based on plt results reported.No harm was reported due to the unnecessary transfusions and 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-22 362; SW SE-22362
• MDR Report Key: 18636644
• Report Number: 1000515253-2024-00001
• Device Sequence Number: 7725675
• Product Code: JOY
• UDI-Device Identifier: 07350040972021
• UDI-Public: 07350040972021
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/02/2024
• Report Date (Section F): 02/02/2024

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: 01/04/2024
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• 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: 57 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/02/2024