MAUDE MDR 4884268

MDR report key
4884268
Report number
MW5043431
Event key
0
Event type
3
Date received
2015-06-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CERNER MULTUMCPOE SYSTEMCERNERNSX

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-250

Event Narratives#

D

Patient 1

PT WAS ADMITTED WITH MULTIPLE ALLERGIES DOCUMENTED INCLUDING DAIRY AND MILK. THEY WERE ON A HOME MEDICATION OF A DAIRY-FREE PROBIOTIC POWDER. PER OUR POLICY WE DO NOT CONTINUE HOME POWDERS/LIQUIDS THAT WE CANNOT IDENTIFY (COMPARED TO A TABLET WITH MARKINGS FOR IDENTIFICATION). THEY INITIATED OUR FORMULARY PROBIOTIC (FLORANEX). AFTER THE FIRST DOSE, THE PT EXPERIENCED SYMPTOMS THAT COULD BE RELATED TO HER ALLERGY BUT IT WAS NOT DISCOVERED UNTIL THE SECOND DOSE THAT THE FLORANEX CHEWABLE CONTAINS MILK. THERE WAS NO ALERT IN OUR CPOE SYSTEM ((B)(6)) TO FLAG THE PROVIDER OR PHARMACIST OF THIS ALLERGY WHEN THE FLORANEX WAS ORDERED/VERIFIED. IN ADDITION, WHEN TRYING TO INVESTIGATE IF FLORANEX COULD HAVE BEEN THE CAUSE OF THE ALLERGIC REACTION, THE PROVIDER/ PHARMACIST WENT TO (B)(6) WHICH DOES NOT HAVE THIS LISTED AS A WARNING, PRECAUTION OR CONTRAINDICATION (AS IT DOES WITH OTHER FOOD/DRUG ALLERGIES SUCH AS PROPOFOL WITH EGG/SOY). IT IS ONLY LISTED UNDER DOSAGE FORMS WHICH IS NOT THE FIRST PLACE THE PROVIDER OR PHARMACIST WHO TYPICALLY SEARCH FOR THIS INFO. WE ARE NOTIFYING BOTH (B)(6) TO SUGGESTION CHANGES TO THEIR DATA BASE. UNTIL THIS IS DONE, WE ARE ADDING A CUSTOM ALERT IN (B)(6) TO NOTIFY THE PHARMACIST. WE WANTED TO SHARE THIS INFO AS IT IS VULNERABILITY IN A CPOE SYSTEM THAT MANY HOSPITALS USE. IT PRESENTS A SAFETY CONCERN AS MORE PTS COME INTO HOSPITALS ON HOME "DIETARY SUPPLEMENTS" THAT ARE NOT FDA REGULATED AND MAY NOT HAVE SAFETY CHECKS SUCH AS ALLERGY AND INTERACTION CHECKING BUILT INTO CPOE DATABASES. I THOUGHT THIS MIGHT BE A GOOD ITEM FOR THE (B)(6) NEWSLETTER. PLEASE LET ME KNOW IF YOU NEED ANY ADD'L INFO. (B)(6).