MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-21 for DI-60 DI-60 COMPLETE CC286297 manufactured by Cellavision Ab.
[73516813]
This event only occurs if the user incorrectly places a sp-10 barcode read error slide, on the di-60. When the sp-10 creates this type of slide the order id begins with the prefix 'err. ' the di-60 instructions for use, section a3 - materials specification, section a. 3. 4 - barcodes, instructs the operator: "all slides must be labeled with an order id in the form of a barcode. The barcode must contain only the order id and no other order data. The order id may be up to 24 characters (ascii), including spaces. It must not begin with:? Pb? Bfs? Err? Qc (reserved for cell location test slides)? A space" if the slide is placed on the di-60, it will alert the operator to a barcode read error. The operator has the ability to reassign the order id to identify any barcode read errors generated by the di-60. The di-60 instructions for use, section 4 - verifying processed slides, section 4. 1. 7 - edit order id states "the order id can only be edited if it starts with "er". If a barcode cannot be read, an image of the barcode will be saved into the database record. The slide will be given an order id starting with "err" followed by the current date and time (erryyyymmddhhmmss) and processed using default settings. " the err barcode labels generated by the sp-10 have a completely different range of numbers (e. G. Err000000001) than the err order-ids created by the di-60 (e. G. Err20170323101925). This is an indication to the operator that the incorrect slide was placed on the di-60. There have been no reported cases of sample mismatch, however the possibility exists. The event was identified by a sysmex cas during installation of the di-60 device located at customer site: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73516814]
A sysmex clinical applications specialist (cas) was onsite performing installation of the di-60 device. The cas discovered the di-60 displayed an incorrect image of a slide identification (id) label. At the time it was determined the sp-10 generated light printing of the slide id label which caused the di-60's inability to properly read the barcode. An image of the slide id label is taken when an error occurs and is displayed with the assigned error id#, by the di-60. In this instance, the image displayed was from a different slide that had a previous error. The observed event is as follows: the sysmex sp-10 slide preparer creates and labels blood smear slides. Slide 1 was prepared and labeled with no issue. Slide 2 had a barcode read error and was assigned a sequential error number by the sp-10 (i. E. Err000000001). The sp-10 alerted the operator of the error with an audible alarm and the assigned error id# appeared on the work list highlighted in red. The operator must follow the on screen instructions to resolve the error. The slide is held by the sp-10 for further verification by the operator. The operator did not verify the slide and incorrectly placed slide 2 on the di-60. Slide 1 was processed by the di-60 and generated a barcode read error (i. E. The barcode print is too faint, blurry, marking through barcode, etc. ) and assigned the slide an error id# using the format of 'erryyyymmddhhmmss. The di-60 took a digital image of slide 1's id label. Slide 2 was processed by the di-60, which read the sp-10 error number 'err000000001' and incorrectly attached an image taken from an error generated previously, in this case the image of slide 1 id label. There is a possibility that the operator may review the error slide 'err000000001' (slide 2) with the image of slide 1 id label displayed and manually identify the slide incorrectly. This may result in a sample mismatch. No erroneous results were reported as the analyzer was being implemented and was not yet released to the operator. A sysmex 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. The issue was escalated to cellavision, manufacturer of the di-60. A preliminary investigation report from cellavision dated march 10, 2017 identified a di-60 software anomaly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2017-00010 |
| MDR Report Key | 6513464 |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-21 |
| Date of Event | 2015-10-22 |
| Date Facility Aware | 2015-10-22 |
| Report Date | 2017-03-10 |
| Date Reported to Mfgr | 2017-03-10 |
| Date Added to Maude | 2017-04-21 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DI-60 |
| Generic Name | AUTOMATED CELL-LOCATING DEVICE |
| Product Code | JOY |
| Date Received | 2017-04-21 |
| Model Number | DI-60 COMPLETE |
| Catalog Number | CC286297 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLAVISION AB |
| Manufacturer Address | BATALJONSGATAN 10 J?NK?PING, SE-551 10 SW SE-551 10 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-21 |