MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-01-06 for CERNER REGISTRATION MANAGEMENT RELEASES 2010.01 THROUGH 2015.01 manufactured by Cerner Corporation.
[35214612]
Cerner distributed a priority review flash notification on december 31, 2015 to all potentially impacted client sites. The software notification includes a description of the issue, an alternative workflow, a method to identify data that might be affected by this issue, and notification that a software modification has been developed to address the issue fo 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
[35214613]
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 malfunctioned 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 registration management nor is it currently actively regulated by the fda. The issue involves cerner registration management in that when relationships are added to a person using the maintain relationships dialog box, information on the disease alerts list may not be copied from relationship type to another (opened from registration conversations) to add next of kin relationships to patients. Existing disease alerts may be removed for persons who are listed as next of kin and have an emergency contact relationships. Disease alerts are used to inform the staff of necessary infectious disease precautions to ensure staff safety and could potentially adversely affect patient safety as well. 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 | 1931259-2016-00001 |
| MDR Report Key | 5348053 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-01-06 |
| Date of Report | 2016-01-07 |
| Date of Event | 2015-07-24 |
| Date Mfgr Received | 2015-07-24 |
| Date Added to Maude | 2016-01-06 |
| 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 64117 |
| Manufacturer Country | US |
| Manufacturer Postal | 64117 |
| Manufacturer Phone | 8162011368 |
| Manufacturer G1 | CERNER CORPORATION |
| Manufacturer Street | 2800 ROCKCREEK PARKWAY |
| Manufacturer City | KANSAS CITY 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 REGISTRATION MANAGEMENT |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2016-01-06 |
| Model Number | RELEASES 2010.01 THROUGH 2015.01 |
| 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 64117 US 64117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-06 |