FDA Adverse Event
Summary report: N
EHR
MDR report key: 13059754
·
Received December 20, 2021
Report
- Report Number
- MW5106188
- Date Received
- December 20, 2021
- Report Date
- November 24, 2021
- Manufacturer
- OMNICELL
- Product Code
- OUG
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THERE HAVE BEEN THREE OCCURRENCES REPORTED BY OUR NURSING STAFF OF OUR OMNICELL AUTOMATED DISPENSING CABINETS DISPLAYING DISCONTINUED MEDICATIONS ON THE NURSING UNIT CABINET MANY MONTHS AFTER THE ORDER WAS DISCONTINUED. TWO OCCURRENCE WERE IN XXX 2021 AND THE THIRD WAS THIS MONTH, XXXXXX 2021 (6 MONTHS AFTER). IN THE MOST RECENT CASE, THE NURSE REPORTED THE ISSUE AND OMNICELL NEEDED TO BE CONTACTED TO RESOLVE THE ISSUE AS OUR EHR NO LONGER DISPLAYED THE DISCONTINUED MEDICATION TO RESEND THE DISCONTINUE MESSAGE. IN THE MOST RECENT CASE, BECAUSE THE PATIENT ALSO HAD AN ACTIVE ORDER ON THE PROFILE THE INCORRECT MEDICATION DOSE WAS GIVEN TO THE PATIENT BEFORE THE ISSUE WAS IDENTIFIED. THERE WAS NO PATIENT SAFETY IMPACT IDENTIFIED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1939624 | EHR | MEDICAL DEVICE DATA SYSTEM | OUG | OMNICELL | |||
| 1939625 | EHR | MEDICAL DEVICE DATA SYSTEM | OUG | OMNICELL | |||
| 1939647 | EHR | MEDICAL DEVICE DATA SYSTEM | OUG | OMNICELL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |