MAUDE Adverse Event Report: MEDTRONIC MINIMED 630 INSULIN PUMP; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 630G

Device Problem Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 08/21/2020

Event Type  Injury  

Event Description

When changing insulin site pump does not deliver insulin then manually proceed to correct blood sugar.The following morning wakes up with low blood sugar.Fda safety report id# (b)(4).

• Brand Name: 630 INSULIN PUMP
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 10453593
• MDR Text Key: 204534619
• Report Number: MW5096258
• 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: 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 630G
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR
• Patient Weight: 59