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

Model Number 630G

Device Problem Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

630 g minimed pump failed and gave me extra insulin instead of stopping the pump.Fda safety report id # (b)(4).

• Brand Name: 630 G MINIMED INSULIN PUMP
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 13602448
• MDR Text Key: 286373283
• Report Number: MW5107721
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/24/2022
• Patient Sequence Number: 1
• Treatment: ADVAIR; ALDACTONE; ALLEGRA; BUSPAR; CRESTOR; DEXCOM 6; LASIX; METOPROLOL; POTASSIUM; PRILOSEC; REGLAN; THYROID; TOPIRAMATE; TYLENOL; VITAMIN D3; ZETIMIBE; ZOLOFT
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White