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	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported a slide with sample id (b)(6) was being processed by the di-60 when the sysmex slide conveyor shuttle, cf-60 connection unit, generated an error.The user cleared the error and removed slides from the cf-60, but one slide remained in the gripper of the di-60.The system resumed operation with the processing of the subsequent slide, sample id (b)(6).Upon result review, the user recognized a discrepancy between the di-60 cell imaging results and xn-10 cell counter analysis results.Further investigation by the user determined di-60 results from sample id (b)(6) were incorrectly associated with sample id (b)(6).No erroneous results were reported.No patient harm occurred due to the event.The event was escalated to cellavision, the manufacturer of the di-60, for investigation.

• 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: 13563855
• Report Number: 1000515253-2022-00003
• Device Sequence Number: 11255080
• Product Code: JOY
• UDI-Device Identifier: 07350040972021
• UDI-Public: 07350040972021
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/18/2022
• Report Date (Section F): 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 02/15/2022
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/18/2022