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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 14000
Device Problem Insufficient Information
Event Date 07/10/2015
Event Type  Injury  
Manufacturer Narrative

The device was not returned for evaluation. We are unable to determine if any product condition could have contributed to the reported hospitalization for surgery and low bg's were noted. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod user guide warns, "test results below 70 mg/dl mean low blood glucose (hypoglycemia). If you get results below 70 mg/dl, but do not have symptoms of hypoglycemia, repeat the test. If you have symptoms or continue to get results that fall below 70 mg/dl, follow the treatment advice of your healthcare provider," and it advises ¿hypoglycemia can occur even when a pod is working properly. Never ignore the signs of low blood glucose (no matter how mild). If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness. If you suspect that your blood glucose level is low, check your bg level to confirm. ¿.

 
Event Description

The customer reported that while she was in the hospital for hysterectomy her bg went to 36 mg/dl and was treated with glucose by iv. No further information has been received.

 
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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 Key5018085
Report Number3004464228-2015-00572
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/01/2016
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL41719
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/26/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/20/2015 Patient Sequence Number: 1
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