FDA.reportPublic FDA data

MAUDE MDR 5479532

MDR report key
5479532
Report number
MW5060731
Event key
0
Event type
3
Date of event
2016-02-11
Date received
2016-03-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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
1ELECTRONIC MEDICAL RECORDMDDS/EHREPICNSX* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-0101. L; 2. O

Event Narratives#

D

Patient 1

BLOOD CULTURES WERE ORDERED AS PART OF A FEVER WORK UP. THE RESULTS WERE RANDOMLY AND INTERMITTENTLY ELECTRONICALLY TRANSMITTED TO THE EHR DATA STORAGE LIBRARY, BUT THERE WAS NOT ANY WARNING OR NOTIFICATION THAT A POSITIVE BLOOD CULTURE WAS REPORTED. MORE THAN 24 HOURS ELAPSED BEFORE ANY CLINICIAN KNEW AND ANTIBIOTICS STARTED. THE DELAY, COMMONLY CAUSED BY SILENT DELIVERY OF LIFE CRITICAL RESULTS, WAS LIFE THREATENING IN THIS CASE.