MAUDE Adverse Event Report: CELLAVISION AB AUTOMATED DIGITAL CELL MORPHOLOGY ANANLYZER DI-60; AUTOMATED CELL-LOCATING DEVICE

Model Number	DI-60
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Patient Data Problem (3197)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the problem could be performed without the return of the actual device (di-60) since the evaluation involved the installed software which could be evaluated on any di-60.In order to eliminate the risk for a mix-up, the software bug has been resolved and corrected versions of the software shall be released.Evaluated sw installed on similar devic.
Event or Problem Description
Sysmex has reported a potential issue for the di-60 which was discovered by their clinical applications team during an installation at a customer site in the us.If a customer first processes a slide (henceforth known as slide 1) with an unreadable barcode, and then afterwards process a slide with a barcode starting with err (henceforth known as slide 2), then the image of the barcode of slide 1 will be visible in the patient information dialog of slide 2 (bug #8093).This will give the false impression that the di-60 barcode reader could not read the barcode of slide 2.If the user is not careful, there is a risk that the user assigns an incorrect order id (the order id belonging to the first slide) to the second slide.If a user tries to assign slide 2 the same order id slide 1 before the slide 1 has been signed, the user will get an error message, informing the customer that the order id already exists.If slide 1 has already been signed, it is possible to give slide 2 the same order id as slide 1.In that case it is likely that the lis will alert the customer that an error has been made, since the lis then receives two sets of results for the first slide and none for the second.The lis may also discard the second result since there is no matching order.However, it is possible that there are lis systems that will accept the second result and then there is a risk for mix-up of results.No erroneous results were reported as the analyzer was being implemented and was not yet released to the operator.A sysmex clinical application specialist (cas) was able to recreate the issue at two different customer sites, on (b)(6) 2017, during installation of di-60 devices.Again no erroneous results were reported.

• Brand Name: AUTOMATED DIGITAL CELL MORPHOLOGY ANANLYZER DI-60
• Common Device Name: AUTOMATED CELL-LOCATING DEVICE
• Manufacturer (Section D): CELLAVISION AB; ideon science park; lund, SE-22 3 70; SW SE-223 70
• MDR Report Key: 6553709
• Report Number: 3003630693-2017-00001
• Device Sequence Number: 16318245
• Product Code: JOY
• UDI-Device Identifier: 07350040972021
• UDI-Public: 07350040972021
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

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: Other
• Device Model Number: DI-60
• Device Catalogue Number: CC286297
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1