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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 02/07/2014
Event Type  Injury  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm any product malfunction or other product condition to have contributed to the patient's hypoglycemia and emergency room visit. Qualification records were reviewed and the product lot met all acceptance criteria.

 
Event Description

The patient's mother report on (b)(6) 2014 her daughter's blood glucose, carbohydrate intake and insulin history is as follows: (b)(6). Her daughter was lying on the floor shaking so she called 911. At 10:20 pm 23 grams (apple juice box). From 10:27pm to 10:55pm her bg was reading between 3. 1 (56 mg/dl) to 3. 9 mmol/l (70 mg/dl). At 11:29pm the paramedics arrived her bg was reading 5. 6 mmol/l (101 mg/dl). She was taken to the emergency room and they placed her on an intravenous saline drip to prevent dehydration. She stayed at the emergency room for about 5. 5 hours and at 1:59 am her bg result were 17. 1 mmol/l (308 mg/dl).

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
bedford MA
Manufacturer Contact
michael doyle
9 oak park dr.
bedford , MA 01730
7814575000
MDR Report Key3674370
Report Number3004464228-2014-00278
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date06/01/2015
Device MODEL Number15880
Device Catalogue NumberZXR425
Device LOT NumberL40730
OTHER Device ID Number0016779
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2013
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: 03/06/2014 Patient Sequence Number: 1
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