MAUDE Adverse Event Report: MEDTRONIC MINIMED XMTR MMT-7811NA GST3C LOCKOUT; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-7811NA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Diabetic Ketoacidosis (2364)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer called and reported that they got admitted due to high blood glucose on (b)(6) 2018 with unknown blood glucose levels at the time of the incident.The customer was at 189 mg/dl at the time of the call.The customer stated that the sensors was not suspending the pump or alerting them before and on lows.The customer used food to treat the lows.The customer was found unconscious after a low and went up to 80 mg/dl 4 hours later.The customer got hospitalized for the low and got pain and nausea medication.The customer had not drunk enough juice to compensate for the low.The customer experienced low symptoms such as vomiting, feeling sick to their stomach, fatigue, extreme pain in the legs, and possible loss of consciousness.The customer also had high blood glucose incidents.Troubleshooting was completed for the low but not completed for the highs.On (b)(6) 2018, the customer went back to the emergency room after vomiting and fatigue continued.The customer was then transferred to a hospital, determined to be in diabetic ketoacidosis and hospitalized for 10 days.The customer had performed a set change for the first time and the infusion set had come loose.The customer also had the sensor on while in a tub for over 30 minutes.The customer was not wearing the insulin pump during the incident, within less than 48 hours.The customer was given intravenous fluids to treat.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Event was reported in error.

• Brand Name: XMTR MMT-7811NA GST3C LOCKOUT
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7494652
• MDR Text Key: 107607196
• Report Number: 2032227-2018-02972
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7811NA
• Device Catalogue Number: MMT-7811NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PUMP MMT-1780KPK 670G PATHWAY BLACK MG
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 130