FDA.reportPublic FDA data

MAUDE MDR 8660545

MDR report key
8660545
Report number
2954323-2019-04360
Event key
0
Event type
3
Date of event
2019-04-04
Date received
2019-05-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DEVIN DIRSTINE
Address
1360 SOUTH LOOP ROAD ALAMEDA CA 94502 US
Phone
510-510-5108
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FREESTYLE LIBRE 14 DAYFLASH GLUCOSE MONITORING SYSTEMABBOTT DIABETES CARE INCPZE71940-01R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-3101. R

Event Narratives#

N

Patient 1

THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

D

Patient 1

CUSTOMER REPORTED EXPERIENCING AN ADVERSE SKIN REACTION AFTER 6 DAYS OF WEARING AN ADC FREESTYLE LIBRE SENSOR. CUSTOMER DEVELOPED INFLAMMATION AND SKIN IRRITATION UPON APPLICATION OF THE SENSOR AND THE REACTION SPREAD TO HER SHOULDER, BACK AND THIGHS. CUSTOMER HAD CONTACT WITH A DERMATOLOGIST WHO PRESCRIBED HYDROCORTISONE 2.25% CREAM FOR TREATMENT. BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.