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

Model Number 15880

Device Problem Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.The user reported that the cannula had pulled out of the infusion site.A dislodged cannula could interrupt insulin delivery and may lead to hyperglycemia.The omnipod¿s user guide warns to "check often to make sure the pod and soft cannula are securely attached and in place.A loose or dislodged cannula may interrupt insulin delivery.Verify there is no wetness or scent of insulin, where as may indicate the cannula has dislodged," "because insulin pods use only rapid-acting insulin, users are at increased risk for developing hyperglycemia (high blood glucose) if insulin delivery is interrupted," "if your reading is above 27.8 mmol/l [500 mg/dl], the pdm displays ¿high check for ketones!¿ this indicates severe hyperglycemia (high blood glucose)," and "test results greater than 13.9 mmol/l [250 mg/dl] mean high blood glucose (hyperglycemia).If you get results above 13.9 mmol/l [250 mg/dl], but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results above 13.9 mmol/l [250 mg/dl], follow the treatment advice of your healthcare provider.".

Event Description

The customer reported her blood glucose reached 24.0 mmol/l (432 mg/dl) and that the cannula had slipped out of the skin.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, 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: david simard ; 600 technology park drive; suite 200; billerica, MA ; 9786007000
• MDR Report Key: 5027231
• MDR Text Key: 23934111
• Report Number: 3004464228-2015-00629
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 15880
• Device Catalogue Number: ZXR425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR