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

Model Number 18900-5C

Device Problem Unable to Obtain Readings (1516)

Patient Problem Hypoglycemia (1912)

Event Date 07/19/2020

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device is not being returned for investigation.We are unable to determine if any product malfunction or other product condition could have contributed to the reported hypoglycemia and hospitalization.Lot release records were reviewed and the product lot met all acceptance criteria.For your reference, insulet modified our internal investigation finding codes effective 25 may 2020 as part of an effort to improve the classification of findings to improve the power of trending data and make the findings more intuitive.The new findings codes will use the system of finding category (e.G.Hardware component), followed by the affected component (e.G.Needle), followed by the condition (e.G.Bent).Therefore you may notice findings that appear to be new or different but in fact are just renamed for improved data value.Insulet would be happy to explain any mapping of the old to new finding codes if you have any questions.

Event Description

It was reported that the patient was hospitalized over night due to low blood glucose (bg) levels of 1.9 mmol/l (34.2 mg/dl).The patient stated having issues with the omnipod personal diabetes manager (pdm) bg meter, not being able to see the readings despite trying several times and using different strips.No information was provided on the type of treatment received at the hospital as the patient has no recollection of the events.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• 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: 10313621
• MDR Text Key: 200038091
• Report Number: 3004464228-2020-11759
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081120067
• UDI-Public: (01)10385081120067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18900-5C
• Device Catalogue Number: ENT450
• Device Lot Number: L60963
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR