MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for SWRE KIT,KALUZA C 10 USER NETWORK EDUCATIONAL LICE C10580 manufactured by Beckman Coulter.
[116058627]
Kaluza 2. 0 software is an ruo (research use only) product; therefore there is no impact to patient results for this event. However, there is a similar product available which is labeled for clinical use (ivd), kaluza c, 10 user network educational license software kit (pn: c10580). The technical support specialist confirmed the problem filed this complaint and escalated the issue to the software engineer. The problem was confirmed by the software engineering team and extends to all ruo license types and clinical versions of the stand-alone analysis software. The following was observed: when a new file is uploaded the keywords created in the cytometer software are correctly updated in the info plots. The keyword values on the lis preview/export screen never update after the template is first created. The first values entered are always displayed. Secondary sample identifiers (ids) can be included as keywords and would be transmitted incorrectly; however the primary sample id is not coded as a keyword and would not be impacted. A stop ship (mia-18-0257-q) was implemented on 20-july-2018 for both ruo and clinical versions of the software. The issue was escalated to post market for assessment.
Patient Sequence No: 1, Text Type: N, H10
[116058628]
The customer reported a problem with kaluza 2. 0 software in which keywords entered by the customer did not properly transfer to the laboratory information system (lis). The lis template saves the keyword information of the file loaded when the template was created. When a new file is dragged in, the keywords are not updated. Customers are placing information needed for result calculation and filing in the sample id fields for transmission to lis. These fields (such as cbc, lymph %, dilution factor, sample id, serial #) are then used on lis to calculate final patient result. If a customer does not realize the fields transmitted are for wrong data file, the results will be incorrect. Kaluza 2. 0 is an ruo (research use only) product; therefore there is no impact to patient results for this event. However, there is a similar product available which is labeled for clinical use (ivd), kaluza c, 10 user network educational license software kit (pn: c10580).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2018-01036 |
| MDR Report Key | 7741595 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-07-02 |
| Date Facility Aware | 2018-07-02 |
| Date Mfgr Received | 2018-09-11 |
| Date Added to Maude | 2018-08-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802874 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 331962031 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-0911/2018-013C |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | SOFTWARE FOR DIAGNOSIS/TREATMENT |
| Product Code | OSN |
| Date Received | 2018-08-01 |
| Model Number | SWRE KIT,KALUZA C 10 USER NETWORK EDUCATIONAL LICE |
| Catalog Number | C10580 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-01 |