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

Device Problems Premature Discharge of Battery (1057); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2022

Event Type  Injury  

Event Description

I have had trouble keeping the battery working in my 630g insulin pump.It sometimes tells me that i need a new battery and if i don't check it immediately, it will go black.Every time i change the battery it is not a quick easy change.The metal on the cap falls off and i find it hard to get it just right to get it back on.I do not see any black dots on mine.I have always gotten it back working but it takes me several times putting the cap back on.I have also lost the contour next blood sugar tester after going through security at the airport out of my carry on.Fda safety report id# (b)(4).

• Brand Name: 630 G MEDTRONICS INSULIN PUMP
• Type of Device: AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 14633015
• MDR Text Key: 293710029
• Report Number: MW5110187
• 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: 06/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CONTOUR NEXT BLOOD TESTER
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White