• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 14500A
Device Problem Device Operates Differently Than Expected
Event Date 07/16/2016
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 diabetic ketoacidosis. No lot release records were reviewed, as the product lot number was not provided. The omnipod¿s user guide warns to "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 "if left untreated, dka can cause breathing difficulties, shock, coma, and eventually death. " it advises ¿the easiest and most reliable way to avoid dka is by checking your blood glucose at least 4¿6 times a day. Routine checks allow you to identify and treat high blood glucose before dka develops. ".

 
Event Description

The patient reported having a blood glucose level that reached 437 mg/dl after wearing the pod on their arm between 4 and 24 hours. After four hours of high blood glucose, the pod was changed and ketones were checked. In the morning, there were no ketones, and then later, there were large ketones. The patient was admitted to the hospital and diagnosed with diabetic ketoacidosis. He was placed on an insulin drip which brought his blood glucose down to 105mg/dl. New pod was placed on and his blood glucose level increased to 380 mg/dl. The doctor and mother both feel the pdm is having issues communicating with the pod, since the pods didn't give errors and the pods appeared normal and the insulin was fine. Pdm was requested to be replaced. History: icr: (breakfast)1: 14; (lunch) 1:88; (dinner) 1:14; 10:44pm deactivated ( in hospital); 932 p suspend begin (in hospital); 932pm basal. 6; 9:32 resume (in hospital); 7:37 suspend done (in hospital); 7:37 suspend begin (in hospital); 7:36 basal. 60 units; 7:36 resume (in hospital); 5:36 suspend (in hospital); 3:00 bg 431; 2:09 bolus 2. 6; 2:08 bg 498; 12:36 bolus 4. 8 carb 15; 1235 bg 394; 9:00 basal. 6 856 bolus 2. 15; 8:56 bg 295; 6:02 bolus 2. 05 bg 406.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
suite 200
billerica MA 01821
Manufacturer Contact
derek sammarco
600 technology park drive
suite 200
billerica , MA 01821
9786007000
MDR Report Key5878200
Report Number3004464228-2016-02381
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 07/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number14500A
Device Catalogue NumberZXP425
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/20/2016
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: 08/16/2016 Patient Sequence Number: 1
-
-