FDA.reportPublic FDA data

MAUDE MDR 8231832

MDR report key
8231832
Report number
MW5083011
Event key
0
Event type
3
Date of event
2018-01-01
Date received
2019-01-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWNDISPENSER, SOLID MEDICATIONUNKNXBI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-080

Event Narratives#

D

Patient 1

IN 2018 PRESCRIPTION FOR SINGULAIR 10MG RAN THROUGH FOR A PT AND REVERSED ABOUT 10 SECONDS LATER. NOT SURE WHY THIS OCCURRED BUT IT STILL TRIGGERS OUR ROBOT TO COUNT THE MEDICATION. AROUND THE SAME TIME PERIOD, A PRESCRIPTION WAS GENERATED FOR SINGULAIR 5MG FOR A DIFFERENT PT. THIS STRENGTH IS NOT COUNTED BY THE ROBOT. THE ROBOT SINGULAIR 10MG WAS THEN PLACED IN THE WRONG PTS BAG. THE ERROR WAS NOT NOTICED FOR 27 DAYS OUT OF 30. THE PT CALLED AND NOTICED THEY HAD THE INCORRECT MEDICATION. A REPLACEMENT BOTTLE WAS GIVEN AND TOXICITY INFO LOOKED SAFE AND NO ADVERSE EVENTS WERE REPORTED. THIS WAS MISSED CLEARLY AND ILLUSTRATES A NEW LEVEL OF AUTOMATED POTENTIAL DRUG ERRORS. A MULTI POINT CHECKING STANDARD STILL NEEDS TO BE ADHERED WHICH VERIFIES BUT IS NOT LIMITED TO THE MEDICATION AND WHAT IS IN THE BOTTLE AND WHOM IT IS LABELED FOR. (B)(6), ACCESS NUMBER: (B)(4).