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

Model Number 14500-5A

Device Problem Unable to Obtain Readings (1516)

Patient Problem Hypoglycemia (1912)

Event Date 12/06/2019

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 and hypoglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system user guide: model: ust400.17845-5a-aw rev b 09/17.Checking your blood glucose: chapter 4 / page 36.Warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia).Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider.

Event Description

It was reported that the patient's blood glucose levels (bg) reached 65 mg/dl while in gymnastics and that the omnipod personal diabetes manager (pdm) was given an meter error 2.She going home with her parent, when the patient fainted.The ambulance was called and upon their arrival they treated the patient with a manual injection of glucagon.It was reported that the patient was in the hospital, but not clear if the ambulance took them.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: jordan biswurm ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 9535159
• MDR Text Key: 173960101
• Report Number: 3004464228-2019-14028
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003(11)171222(10)L60794
• 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
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14500-5A
• Device Catalogue Number: UST400
• Device Lot Number: L60794
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 6 YR