MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-26 for DI-60 DI-60 COMPLETE CC286297 manufactured by Cellavision Ab.
[73906202]
This event only occurs if the user incorrectly places an 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
[73906203]
A sysmex clinical applications specialist (cas) was onsite performing installation of the di-60 device. The cas recreated an issue where the di-60 stored an image of a previous bar code read error. When an error slide from the automated slide preparation unit (sp-10) is analyzed, the di-60 displays the image of a previous di-60 bar code read error. The observed event is as follows: the sp-10, which creates and labels blood smear slides, creates slide 1 with no issues. Slide 2 has a barcode read error and is assigned a sequential error number by the sp-10 (i. E. Err000000001). The sp-10 alerts the operator of the error with an audible alarm and the assigned error id# appears 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 does not perform further verification and incorrectly places slide 2 on the di-60. Slide 1 is processed by the di-60 and generates a barcode read error (i. E. The barcode print is too faint, blurry, markings through barcode, etc. ). The di-60 assigns the slide an error id# using the format of 'erryyyymmddhhmmss' and stores a digital image of slide 1's id label. Slide 2 is processed by the di-60, which reads the sp-10 error number 'err000000001' and incorrectly attaches an image taken from an error generated previously; in this case, the image of slide 1 id label is displayed. 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. The issue was escalated to cellavision, manufacturer of the di-60. A preliminary investigation report from cellavision dated (b)(6) 2017 identified a di-60 software anomaly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2017-00012 |
| MDR Report Key | 6522901 |
| Date Received | 2017-04-26 |
| Date of Report | 2017-04-26 |
| Date of Event | 2017-02-14 |
| Date Facility Aware | 2017-02-14 |
| Report Date | 2017-03-10 |
| Date Reported to Mfgr | 2017-03-10 |
| Date Added to Maude | 2017-04-26 |
| 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 | 2017-04-26 |
| Model Number | DI-60 COMPLETE |
| Catalog Number | CC286297 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELLAVISION AB |
| Manufacturer Address | MOBELVAGEN 5 JONKOPING, SE-553 05 SW SE-553 05 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-26 |