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.

MAUDE Entry Details

Report Number3004464228-2020-04721
MDR Report Key9908741
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-06-28
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
Returned To Mfg2020-03-23
Model Number18320
Catalog NumberBLE-I1-529
Lot NumberPD1C06281951
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerINSULET CORPORATION
Manufacturer Address100 NAGOG PARK ACTON MA 01720 US 01720


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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