MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-14 for CERNER MILLENIUM - DYNAMIC DOCUMENTATION manufactured by Cerner Corporation.
[102454060]
Cerner notified all impacted clients on (b)(6) 2018. The notification includes a description of the issue and instructions on how to correct items erroneously marked "in error". Cerner corporation will provide a follow-up report when the updates are completed for impacted clients.
Patient Sequence No: 1, Text Type: N, H10
[102454061]
The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product. The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's millennium dynamic documentation? , nor are these products currently actively regulated by the fda. This report documents information related to an issue identified with functionality included in cerner's millennium dynamic documentation, ocf in error utility. The issue involves cerner millennium dynamic documentation and occurred when a utility was run to "in error" encounters as requested by a client. The intent was for certain encounters to be cancelled. However, logical domains were not taken into account when the in error utility was run which resulted in clinical event views, displays and reports inadvertently being marked "in error" for clients other than the requesting client. This issue could lead to a delay in patient care because results may not be available for review. This issue could also lead a clinician to place additional orders to run the test again if they believed it hadn't already been completed. Cerner has not received communication on any adverse patient events as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1931259-2018-00002 |
| MDR Report Key | 7339370 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-03-14 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2018-01-05 |
| Date Added to Maude | 2018-03-14 |
| 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 | MS SHELLEY LOOBY |
| Manufacturer Street | 2800 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS CITY MO 64117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 64117 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERNER MILLENIUM - DYNAMIC DOCUMENTATION |
| Generic Name | SOFTWARE, PRODUCT CODE: LNX |
| Product Code | LNX |
| Date Received | 2018-03-14 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERNER CORPORATION |
| Manufacturer Address | 2800 ROCKCREEK PARKWAY KANSAS CITY MO 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-14 |