FDA.reportPublic FDA data

MAUDE MDR 4114532

MDR report key
4114532
Report number
MW5038292
Event key
0
Event type
3
Date of event
2014-05-23
Date received
2014-09-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
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
1SOARIANMDDS/EHRSIEMENSNSX

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-1601. L; 2. O

Event Narratives#

D

Patient 1

THE MDDS DISPLAY OF LABORATORY DATA IS MISLEADING BECAUSE THE DATE AT THE TOP OF THE COLUMN DOES NOT APPLY TO ALL LAB DATA BELOW IN THE SAME GENERAL COLUMN. THUS, THERE MAY BE DATA, FOR INSTANCE A LOW HEMOGLOBIN LEVEL, THAT WAS OBTAINED ONE YEAR AGO, THAT APPEARS IN THE SAME COLUMN AS YESTERDAY'S RESULT. THIS LEADS TO ERRORS AND DANGEROUS DECISIONS, BECAUSE THEY ARE BASED ON DATA THAT IS NOT CURRENT BUT MAY BE THOUGHT TO BE CURRENT. DEVICES WITH SUCH MISLEADING FORMATS SHOULD BE RECALLED.