| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 724ACCESS DOWNTIME VIEWER | SOFTWARE | CERNER CORPORATION | LNX | 724ACCESS DOWNTIME VIEWER TOOLKIT 5.2 (ALL RELEASE | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-09-03 | 0 |
Patient 1
CERNER DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION ON AUGUST 24, 2015 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, AN ALTERNATE WORKFLOW, 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 1
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 724ACCESS REPLICATION MANAGEMENT NOR ARE THESE CURRENTLY ACTIVELY REGULATED BY THE FDA. THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED IN CERNER RETAIL PHARMACY. THE ISSUE INVOLVES 724ACCESS REPLICATION MANAGEMENT SOLUTIONS AND AFFECTS USERS THAT UTILIZE THE 724ACCESS DOWNTIME VIEWER TO PROVIDE ACCESS TO CLINICAL DATA THAT OTHERWISE COULD NOT BE ACCESSED OR VIEWED DURING DOWNTIME. IN 724ACCESS DOWNTIME VIEWER, CLINICAL DATA COULD BE INCOMPLETE ON THE END USERS DEVICE WITHOUT ANY INDICATION. THIS MAY OCCUR IN RARE CIRCUMSTANCES DURING THE REPLICATION PROCESS WHERE THE END USER DEVICE IS NOT PROCESSING DATA AT ITS FULL CAPACITY. PATIENT CARE COULD BE ADVERSELY AFFECTED, AS CLINICAL DECISIONS COULD BE MADE BASED ON INCOMPLETE INFORMATION. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.