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

Model Number 250734

Device Problem Inaccurate Delivery (2339)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 01/19/2023

Event Type  Injury  

Event Description

The omnipod dash insulin pump i was wearing was giving much lower doses of insulin than prescribed.Plus, i got abscesses under the pump while wearing it that caused serious infections.Have gotten 3 abscess.

• Brand Name: OMNIPOD DASH INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 16436756
• MDR Text Key: 310319708
• Report Number: MW5115149
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2023
• Device Model Number: 250734
• Device Lot Number: PD1U03222211
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLODIPINE.; ASPIRIN 81MG.; BENZONATATE.; CARVEDILOL.; CHLORTHALIDONE.; DILTIAZEM.; IBUPROFEN 800.; ISOSOBRIDE.; LANTUX.; LOSARTAN.; MULTI-VITAMIN.; NITRO.; NOVOLOG.; PROTONIX.
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White