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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 No Known Device Problem
Event Date 02/14/2014
Event Type  Malfunction  
Event Description

The pt's father reported on (b)(6) 2014 at 12:17 pm his daughter activated a new pod and her blood glucose, carbohydrate intake and insulin history is as follows: time: 1:12 pm, bg (mmol/l): 23. 7, (mg/dl): 427. Time: 2:22 pm, bg (mmol/l): 20. 9, (mg/dl): 376, cho (g): 50, bolus (u): 6. 40. Time: 4:14 pm, bg (mmol/l): 23. 4, (mg/dl): 421, cho (g): 20, bolus (u): 2. 40. Time: 5. 44 pm, bg (mmol/l): 23. 7, (mg/dl): 427, cho (g): 80, bolus (u): 8. 90. Time: 6:54 pm, bg (mmol/l): 23. 6, (mg/dl): 425. She was taken to the emergency room. Upon arrival the doctor advised to change the pod immediately as they suspected there was something wrong with the pod. The pt's father didn't notice any unusual with the cannula or the pod and the doctor confirmed that the cannula was inserted correctly into the infusion site. She was treated with a manual injection (exact dosage was not provided) and at 9:54 pm her bg was reading 10. 8 mmol/l (194 mg/dl). She was at the er for about 4-5 hours before being released from the hosp.

 
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 pt's hyperglycemia and er visit. Qualification records were reviewed and the product lot met all acceptance criteria.

 
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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 Key3784515
Report Number3004464228-2014-00363
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Foreign,Consumer
Type of Report Initial
Report Date 02/21/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2014
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 Number0000491
Was Device Available For Evaluation? No
Date Manufacturer Received02/21/2014
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: 03/21/2014 Patient Sequence Number: 1
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