FDA.reportPublic FDA data

MAUDE MDR 9908754

MDR report key
9908754
Report number
3004464228-2020-04724
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JORDAN BISWURM
Address
100 NAGOG PARK ACTON MA 01720 US
Phone
978-978-9786
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OMNIPOD INSULIN PUMPPUMP, INFUSION, INSULININSULET CORPORATIONLZG14000ZXP425R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED [ER VISIT/HOSPITALIZATION] AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD INSULIN MANAGEMENT SYSTEM ? USER GUIDE. MODEL: UST400. 17845-5A-AW REV B 09/17. CHECKING YOUR BLOOD GLUCOSE. CHAPTER 4 / PAGE 36. WARNINGS: TEST RESULTS BELOW 70 MG/DL MEAN LOW BLOOD GLUCOSE (HYPOGLYCEMIA). TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA). IF YOU GET RESULTS BELOW 70 MG/DL OR ABOVE 250 MG/DL, BUT DO NOT HAVE SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA (SEE "LIVING WITH DIABETES" ON PAGE 115), REPEAT THE TEST. IF YOU HAVE SYMPTOMS OR CONTINUE TO GET RESULTS THAT FALL BELOW 70 MG/DL OR ABOVE 250 MG/DL, FOLLOW THE TREATMENT ADVICE OF YOUR HEALTHCARE PROVIDER. LIVING WITH DIABETES. CHAPTER 11 / PAGE 119. HYPOGLYCEMIA CAN OCCUR EVEN WHEN A POD IS WORKING PROPERLY. NEVER IGNORE THE SIGNS OF LOW BLOOD GLUCOSE, NO MATTER HOW MILD. IF LEFT UNTREATED, SEVERE HYPOGLYCEMIA CAN CAUSE SEIZURES OR LEAD TO UNCONSCIOUSNESS. IF YOU SUSPECT THAT YOUR BLOOD GLUCOSE LEVEL IS LOW, CHECK YOUR BLOOD GLUCOSE LEVEL TO CONFIRM.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE IN THE 40 MG/DL RANGE WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT CONSUMED SOME BROWN SUGAR, JUICE AND GLUCOSE TABLETS. THE PATIENT HAD CHANGED THE PERSONAL DIABETES MANAGER SETTINGS WHILE AT WORK BY DECREASING INSULIN DOSES BY 75 PERCENT AND BACK TO 100 PERCENT TODAY. ONCE AT THE HOSPITAL THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS, GLUCAGON AND ONDANSETRON. THE PATIENT'S BLOOD GLUCOSE AND INSULIN HISTORY ARE AS FOLLOWS: (B)(6).