OMNIPOD DASH? INSULIN MANAGEMENT SYSTEM 18320 BLE-I1-529

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for OMNIPOD DASH? INSULIN MANAGEMENT SYSTEM 18320 BLE-I1-529 manufactured by Insulet Corporation.

Event Text Entries

[187072369] The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported er visit and diabetic ketoacidosis with hyperglycemia. Lot release records were reviewed and the product lot met all acceptance criteria. Omnipod dash insulin management system? User guide. Model: 18320. 18296-eng-aw rev b 06/18. Changing your pod. Chapter 3 / page 37. Warnings: do not use a pod if you are sensitive to or have allergies to acrylic adhesives, or have fragile or easily damaged skin. Living with diabetes. Chapter 13 / page 171. Infusion site checks at least once a day, use the pod's viewing window to inspect the infusion site. Check the site for: leakage or scent of insulin, which may indicate the cannula has dislodged. Signs of infection, such as pain, swelling, redness, discharge, or heat.
Patient Sequence No: 1, Text Type: N, H10


[187072370] It was reported that the patient's blood glucose (bg) values reached 555 mg/dl. The patient went to the emergency room, where they were diagnosed with diabetic ketoacidosis (dka). The patient was given intravenous (iv) fluids and blood work was given, as treatment. The patient reported that the adhesive was lifted where the cannula is located and the cannula was dislodged, as a result. The patient changed out the pod for a new pod.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004464228-2020-04722
MDR Report Key9908746
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-03-11
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-08-02
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJORDAN BISWURM
Manufacturer Street100 NAGOG PARK
Manufacturer CityACTON MA 01720
Manufacturer CountryUS
Manufacturer Postal01720
Manufacturer Phone9786007000
Manufacturer G1INSULET CORPORATION
Manufacturer Street100 NAGOG PARK
Manufacturer CityACTON MA 01720
Manufacturer CountryUS
Manufacturer Postal Code01720
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOMNIPOD DASH? INSULIN MANAGEMENT SYSTEM
Generic NamePUMP, INFUSION, INSULIN
Product CodeLZG
Date Received2020-03-31
Model Number18320
Catalog NumberBLE-I1-529
Lot NumberPD1C08021951
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINSULET CORPORATION
Manufacturer Address100 NAGOG PARK ACTON MA 01720 US 01720


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-31

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.