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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 14500-5A
Device Problem Insufficient Information
Event Date 09/12/2015
Event Type  Injury  
Manufacturer Narrative

The product was not returned for evaluation. We are unable to determine if any product malfunction or other product condition could have contributed to the reported hypoglycemia, hyperglycemia and er visit. Lot release records were reviewed and the product lot met all acceptance criteria. The omnipod¿s user guide warns " test results greater than 250 mg/dl mean high blood glucose (hyperglycemia). If you get results above 250 mg/dl, but do not have symptoms of hyperglycemia, repeat the test. If you have symptoms or continue to get results above 250 mg/dl, follow the treatment advice of your healthcare provider, and "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 patient's mother reported her daughter had to go to the emergency room and that she had been in two comas as results. The doctor believe that there is something wrong with the pdm as the patient's blood glucose keep going from low to high. Her blood glucose history is as follows: (b)(4).

 
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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
Manufacturer (Section G)
INSULET CORPORATION
600 technology park drive suit
billerica MA
Manufacturer Contact
derek sammarco
600 technology park drive
suite 200
billerica , MA 
9786007000
MDR Report Key5134737
Report Number3004464228-2015-01140
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation Other
Type of Report Initial
Report Date 09/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number14500-5A
Device Catalogue NumberZXP425
Device LOT NumberL60116
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/08/2015 Patient Sequence Number: 1
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