FDA.reportPublic FDA data

MAUDE MDR 2903679

MDR report key
2903679
Report number
2024674-2012-00001
Event key
0
Event type
3
Date of event
2012-11-27
Date received
2012-12-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
10165 MCKELLAR CT. SAN DIEGO CA 92121 US
Phone
858-858-8585
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOFIA INFLUENZA A+B FIASOFIA INFLUENZA A+B FIAQUIDEL CORP.GNXNA20218212222R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-2801. D

Event Narratives#

D

Patient 1

A (B)(6)-MALE IN POOR HEALTH WAS ADMITTED TO THE EMERGENCY ROOM AND DIED SHORTLY AFTER ARRIVAL. PATIENT NASOPHARYNGEAL WASH/ASPIRATE SAMPLE WAS TESTED WITH SOFIA INFLUENZA A+B FIA AND PRODUCED A POSITIVE INFLUENZA B RESULT. SAMPLE WAS RETESTED AND PRODUCED A NEGATIVE RESULT. SAMPLE ALSO TESTED NEGATIVE WITH A DIFFERENT RAPID TEST. PATIENT TESTED POSITIVE FOR STREP A BLOOD CULTURE.

N

Patient 1

INITIAL REPORTER STATED THAT NO OTHER PATIENT HISTORY WAS AVAILABLE, AND THE PATIENT RECORDS COULD NOT BE OBTAINED FROM THE FAMILY.