MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-05-09 for AUTOMATED DIGITAL CELL MORPHOLOGY ANANLYZER DI-60 CC286297 manufactured by Cellavision Ab.
[74797822]
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.
Patient Sequence No: 1, Text Type: N, H10
[74797823]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003630693-2017-00001 |
| MDR Report Key | 6553709 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-05-09 |
| Date of Report | 2017-03-10 |
| Date of Event | 2015-10-22 |
| Date Mfgr Received | 2017-03-10 |
| Date Added to Maude | 2017-05-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MAGNUS JOHNSSON |
| Manufacturer Street | IDEON SCIENCE PARK |
| Manufacturer City | LUND, SE-22370 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-22370 |
| Manufacturer Phone | 6464601648 |
| Manufacturer G1 | CELLAVISION AB |
| Manufacturer Street | IDEON SCIENCE PARK |
| Manufacturer City | LUND, SE-22370 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-22370 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOMATED DIGITAL CELL MORPHOLOGY ANANLYZER DI-60 |
| Generic Name | AUTOMATED CELL-LOCATING DEVICE |
| Product Code | JOY |
| Date Received | 2017-05-09 |
| Model Number | DI-60 |
| Catalog Number | CC286297 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLAVISION AB |
| Manufacturer Address | IDEON SCIENCE PARK LUND, SE-223 70 SW SE-223 70 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-09 |