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

Model Number 14500-5A

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Coma (2417)

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).

• 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: derek sammarco ; 600 technology park drive; suite 200; billerica, MA ; 9786007000
• MDR Report Key: 5134737
• MDR Text Key: 27770254
• Report Number: 3004464228-2015-01140
• 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
• Reporter Occupation: Other
• Report Date: 09/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14500-5A
• Device Catalogue Number: ZXP425
• Device Lot Number: L60116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2015
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR