MULTUM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-29 for MULTUM manufactured by Cerner.

Event Text Entries

[16455504] Description: inaccurate or inappropriate allergies are being documented in pt charts related to "seasonal allergies". The term "seasonale" (brand name of an oral contraceptive) is being accidently selected. In our his seasonal allergies is a diagnosis and the allergy profile records only actual substances, e. G. Pollen, birch, etc. To which a pt is allergic, his does not allow a change to the current display name and even a created synonym brings up the display name of seasonale, i. E. , we cannot hide the display name. The issue has been logged with our his provider cerner. Additionally the following steps are being pursued: (b)(6) is being notified there is a defect that regularly causes a medication error: the declaration of an allergy to an oral combination hormonal contraceptive based on (b)(6) to environmental allergy. Report filed with (b)(6). If (b)(6) responds with the term cannot be modified or hidden, notify fda we are unable to address this through disambiguation using our emr and(b)(6) decision support database. Communication throughout the enterprise "never select seasonale unless pt truly allergic to this medication. " "never record seasonale as an allergy. Seasonal is a diagnosis, not a substance. The allergy profile should only be used to record substances to which a pt is allergic. Medication administered to or used by the pt: no. Pt counselling provided: unk. . (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5043468
MDR Report Key4888351
Date Received2015-06-29
Date of Report2015-04-22
Date Added to Maude2015-07-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMULTUM
Generic NameHIS
Product CodeNSX
Date Received2015-06-29
Device Sequence No1
Device Event Key0
ManufacturerCERNER


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-29

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