MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-04-14 for HEALTHELIFE 2014.12 THROUGH 2016.05 N/A manufactured by Cerner Corporation.
[42754826]
Cerner distributed a priority review flash notification (b)(4) on april 8, 2016 to all potentially impacted client sites. The software notification includes a description of the issue and notice that a software modification has been developed to address the issue for all sites that could potentially be impacted. Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[42754827]
This report documents information related to an issue identified in cerner's healthelife. This solution is a patient portal that provides patients with a view of clinical information from their cerner millennium emr (electronic medical record), including a list of their prescribed medications. The issue occurs when the prescription is filled by a pharmacy using cerner's retail medication manager, and the pharmacy changes the strength, dose or frequency of the ordered medication and adds signature line instructions to describe these changes. The updated signature line instructions are displayed in the portal, conflicting with the dose and frequency of the original prescription which remain unchanged in the portal. Patient care could be adversely affected in the event the patient mistakenly uses the portal as a source of dosage instructions, as the instructions displayed are not for the strength, dose and/or frequency displayed in the portal. This may lead to the patient taking an incorrect amount of the medication resulting in overdose or underdose. 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 | 1931259-2016-00007 |
| MDR Report Key | 5579500 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-04-14 |
| Date of Report | 2016-04-11 |
| Date of Event | 2014-06-26 |
| Date Mfgr Received | 2014-06-26 |
| Device Manufacturer Date | 2014-07-07 |
| Date Added to Maude | 2016-04-14 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEALTHELIFE |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2016-04-14 |
| Model Number | 2014.12 THROUGH 2016.05 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| 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 | 2016-04-14 |