MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-03-18 for CERNER RETAIL PHARMACY ALL RELEASES N/A manufactured by Cerner Corporation.
[40677969]
(b)(4) distributed a priority review flash notification on march 16, 2016 to all potentially impacted client sites. The software notification includes a description of the issue, an alternate workflow, and notification that a software modification is being developed to address the issue for all sites that could be potentially impacted. Cerner corporation will provide a follow-up report when the software modification is available.
Patient Sequence No: 1, Text Type: N, H10
[40677970]
When a multiple-ingredient medication is dispensed through the cerner retail pharmacy solution, it will not check all of the ingredients against a patient's medication history for possible duplicate therapies. Therefore, an alert is not displayed when the patient has an active prescription for a medication containing an ingredient that is also in the multiple-ingredient medication. This could result in a patient taking more of a medication than was prescribed. Cerner has not received communication on any adverse patient events as a result of this issue.
Patient Sequence No: 1, Text Type: D, B5
[50730916]
(b)(4) distributed a priority review flash notification on march 16, 2016 to all potentially impacted client sites. The software notification includes a description of the issue, an alternate workflow, and notification that a software modification is being developed to address the issue for all sites that could be potentially impacted. (b)(4) distributed a follow-up priority review flash notification on june 28, 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. (b)(4) considers the issue to be resolved and no further narrative is required for follow-up.
Patient Sequence No: 1, Text Type: N, H10
[50730917]
The software product mentioned in this medwatch report may not be, by definition, a medical device; however (b)(4) has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product. (b)(4) filing of this medwatch report does not signify (b)(4) belief or understanding that medical device reports are required to be filed for (b)(4) nor is it currently actively regulated by the fda. When a multiple-ingredient medication is dispensed through the (b)(4) solution, it will not check all of the ingredients against a patient's medication history for possible duplicate therapies. Therefore, an alert is not displayed when the patient has an active prescription for a medication containing an ingredient that is also in the multiple-ingredient medication. This could result in a patient taking more of a medication than was prescribed. (b)(4) 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 | 1931259-2016-00005 |
| MDR Report Key | 5510499 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-03-18 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-02-18 |
| Date Mfgr Received | 2016-02-18 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2016-03-18 |
| 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 RETAIL PHARMACY |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2016-03-18 |
| Model Number | ALL RELEASES |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | PHARMACIST |
| 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 | 2016-03-18 |