MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-02-15 for MEDICATION CLINICAL DECISION SUPPORT (MCDS) CONTENT PACKAGE 86068 N/A manufactured by Cerner Corporation.
[38228565]
Cerner distributed a priority review flash notification on (b)(6) 2016 to all potentially impacted client sites. The software notification includes a description of the issue and notification that a software modification has been developed to address the issue for all sites that could be potentially impacted. Cerner corporation considers the issue to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[38228566]
The software product mentioned in this medwatch report may not be, by definition, a medical device; however cerner corporation has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product. Cerner's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for cerner medication clinical decision support (mcds) nor is it currently actively regulated by the fda. This issue involves medication clinical decision support (mcds) and causes a drug-to-drug interaction alert to not be displayed to the end user. This issue occurs if the client is using alert filtering and one (1) major or major-contraindicated drug-to-drug interaction alert should be displayed; the alert will be actively suppressed. If two (2) or more major or major-contraindicated drug-to-drug interaction alerts should be displayed and the client is using alert filtering, the alerts will be displayed correctly. 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 | 1931259-2016-00003 |
| MDR Report Key | 5437238 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-02-15 |
| Date of Report | 2016-02-12 |
| Date of Event | 2016-01-06 |
| Date Mfgr Received | 2016-01-06 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2016-02-15 |
| 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 | MEDICATION CLINICAL DECISION SUPPORT (MCDS) |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2016-02-15 |
| Model Number | CONTENT PACKAGE 86068 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-02-15 |