MAUDE Adverse Event Report: MEDTRONIC MINIMED MINIMED 530G; AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND

Model Number MMT-751NAS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hyperglycemia (1905)

Event Date 05/04/2020

Event Type  Injury  

Event Description

I am a type 1 diabetic and have been for 25 years.I use a medtronic 530g pump to manage my diabetes.I have never had an issue with this pump until monday when i was unable to bring down a high blood sugar.I originally checked my sugar and it was 390.I changed the infusion site thinking it possibly had stopped working and corrected.I then check again an hour later and my sugar had gone up to 420.I tried another hour and was up to 450.I tried changing my site another time without any better results.I lastly tried using manual syringes to correct but at that point in the morning (4.5-5 hours after original check) i was having difficulty fighting back the increasingly high sugar.I went to the hospital due to vomiting and dehydration.I was able to get back out of dke late in the afternoon (about 16 hours after initial check).I stayed the night in the hospital to make sure everything was working and went back home with my sugars in line (keep in mind i was given manual shots at the hospital to work alongside my insulin pump, we were unable at that time to determine what had happened).Upon returning home my sugar started to increase again.I decided to change my site again and to change out my reservoir of insulin.When i looked at my current reservoir i found that there was a large quantity of loose insulin in the pump that had leaked out of the bottom seal of the reservoir.This brought everything together for me in that all of my corrections weren't working because the insulin was going into my pump rather than into me.I do have a picture of what it looked like before i changed my reservoir.I have also saved the failed reservoir.With that i can provide the lot number information from the batch of reservoirs that this one came from as well as any required information from my pump such as ref # and sn.If any of my lab records would be of help, i may be able to get those from the hospital but i do not have them at this time.I can also provide all of my blood sugar test logs if that would help.I did not see where to add additional devices, so i will add them here.Along with the actual pump that i have listed on the next pages the reservoir information is: model: mmt-332a and lot: hg3wuqy.Fda safety report id # (b)(4).

• Brand Name: MINIMED 530G
• Type of Device: AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 10038351
• MDR Text Key: 190503628
• Report Number: MW5094419
• 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: 05/06/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MMT-751NAS
• 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; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 81