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U.S. Department of Health and Human Services

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

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INSULET CORPORATION OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN Back to Search Results
Model Number 18320
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Information (3190)
Event Date 01/08/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation.We are unable to confirm the reported needle mechanism failure or to determine its root cause.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 / pages 48.Warning: check the infusion site after insertion to ensure that the cannula was properly inserted.If the cannula is not properly inserted, hyperglycemia may result.
 
Event Description
It was reported that the needle deployed early when the pod was activated; this indicates a needle mechanism failure.The pod was not worn and patient's mother reported a blood glucose level of 250 mg/dl.
 
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Brand Name
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
Type of Device
PUMP, 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 Key9656118
MDR Text Key193376591
Report Number3004464228-2020-01237
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385082000020
UDI-Public(01)20385082000020(11)181123(17)200523(10)PD1C11231811
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/23/2020
Device Model Number18320
Device Catalogue NumberBLE-I1-529
Device Lot NumberPD1C11231811
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/08/2020
Initial Date FDA Received01/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age14 YR
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