FDA.reportPublic FDA data

MAUDE MDR 3193362

MDR report key
3193362
Report number
MW5030652
Event key
0
Event type
3
Date of event
2013-05-30
Date received
2013-06-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
0
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
1MEDICOOLER MICRO REFRIGERATORPORTABLE MEDICAL SUPPLY REFRIGERATION UNITMEDICOOL, INCLDQ Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-06-210

Event Narratives#

D

Patient 1

PURCHASED A MEDICOOLER ADVERTISED AS A PORTABLE COOLING UNIT THAT OPERATES FROM 110-120V AC OR 12V DC CURRENT. THE FIRST UNIT RECEIVED WAS DEFECTIVE AND STOPPED OPERATION AFTER 30 MINUTES. THE REPLACEMENT UNIT ACTUALLY HEATED MY INSULIN AFTER 4 HOURS OF OPERATION RESULTING IN AN EMERGENCY SITUATION ON AN EXTENDED ROAD TRIP. MY INSULIN WAS NOT SUITABLE FOR USE. I AM A DIABETIC AND RELY ON INSULIN TO STABILIZE MY BLOOD SUGAR. PURCHASE DATE: (B)(6) 2013. I WROTE THE MANUFACTURER A LETTER LETTING THEM KNOW THE UNIT WAS DEFECTIVE. DOCUMENT NUMBER: (B)(4).