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U.S. Department of Health and Human Services

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

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INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 15880
Device Problem Insufficient Information
Event Date 07/23/2015
Event Type  Malfunction  
Manufacturer Narrative

The returned device was evaluated and the investigation found evidence of an internal leak. Its root cause was determined to be a damaged cannula. The damage appeared to have occurred during the manufacturing process. No product lot number was reported therefore no lot release records were reviewed. The omnipod¿s user guide warns "test results greater than 13. 9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia). If you get results above 13. 9 mmol/l [250 mg/dl], but do not have symptoms of hyperglycemia, repeat the test. If you have symptoms or continue to get results above 13. 9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider. ".

 
Event Description

The customer reported her blood glucose and insulin history is as follows: time: 8:06 pm bg (mmol/l) (mg/dl): 25. 8, 464; 9:39 pm, 24. 2, 436, bolus (u): manual injection. The pod was then removed and she was able to activate a new pod. Her bg dropped to 17. 0 mmol/l (306 mg/dl) and then to 10. 0 mmol/l (180 mg/dl).

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
600 technology park drive
suite 200
billerica MA 01821
Manufacturer (Section G)
INSULET CORPORATION
600 technology park drive suit
billerica MA 01821
Manufacturer Contact
david simard
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5022129
Report Number3004464228-2015-00609
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 07/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/11/2016
Device MODEL Number15880
Device Catalogue NumberZXR425
Device LOT NumberL41637
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/03/2015
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2015
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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