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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN

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INSULET CORPORATION OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN Back to Search Results
Model Number 19191
Device Problems Positioning Failure ; Needle
Event Date 01/08/2020
Event Type  Malfunction  
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Brand NameOMNIPOD INSULIN MANAGEMENT SYSTEM
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
100 nagog park
acton MA 01720
Manufacturer (Section G)
INSULET CORPORATION
100 nagog park
acton MA 01720
Manufacturer Contact
jordan biswurm
100 nagog park
acton , MA 01720
9786007000
MDR Report Key9656096
Report Number3004464228-2020-01235
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 01/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number19191
Device Catalogue NumberZXP425
Device LOT NumberL44964
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/05/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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