MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number MMT-751NAB

Device Problem Defective Device (2588)

Patient Problems Atrial Fibrillation (1729); Diabetic Ketoacidosis (2364)

Event Date 08/04/2019

Event Type  Injury  

Event Description

On jul 28, went to er for high blood sugar and was in diabetic ketoacidosis.Stayed in hospital 4 days after being released and getting error messages on pump such as motor error or no suspension.A week later on august 4th my sugar level was high again and i went back to er in a-fib and diabetic ketoacidosis again.The hosp staff thinks it's a pump malfunction.I called medtronic and they stated it was a pump error.They said they would send me a new one.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC PARADIGM INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 8869292
• MDR Text Key: 153721760
• Report Number: MW5088860
• Device Sequence Number: 1
• Product Code: OZO
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2020
• Device Model Number: MMT-751NAB
• Device Catalogue Number: CONF 6323
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 102