MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-12 for MEDICAL DEVICE INTERFACES N/A manufactured by Cerner Corporation.
[97752359]
This issue is isolated to one client, and cerner notified this client of the issue on december 19, 2017. The same day, cerner corrected the configuration and the issue was resolved. 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
[97752360]
The issue involves cerner millennium medical device interfaces (mdi) which provides electronic communication between the lab testing instrument and cerner millennium pathnet system. Due to an incorrect configuration in mdi, when an order was placed for digoxin dta in pathnet, the lab testing instrument ran the dta for creatinine. The test result values for the creatinine dta were saved in pathnet as digoxin levels. Patient care could be adversely affected as clinicians may adjust the dosage of digoxin based on incorrect information which could lead to the patient receiving an overdose or underdose of the medication. 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 | 1931259-2018-00001 |
| MDR Report Key | 7186765 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-12-19 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2017-11-06 |
| Date Added to Maude | 2018-01-12 |
| 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 | MEDICAL DEVICE INTERFACES |
| Generic Name | SOFTWARE |
| Product Code | LNX |
| Date Received | 2018-01-12 |
| Model Number | N/A |
| 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 | 2018-01-12 |