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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 Activation, Positioning or SeparationProblem (2906); Cannula (3036); Needle (3088)
Patient Problem No Information (3190)
Event Date 08/19/2020
Event Type  Malfunction  
Manufacturer Narrative

According to the complainant the device is not being returned for investigation. We are unable to confirm the reported needle mechanism failure. Lot release records were reviewed, and the product lot met all acceptance criteria.

 
Event Description

It was reported that the needle mechanism had a delayed deployment and the pod was unable to be used. The pod was discarded.

 
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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 Key10474973
MDR Text Key205700804
Report Number3004464228-2020-13822
Device Sequence Number1
Product Code LZG
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK192659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2020
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 NumberL45040
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/10/2019
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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