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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED XMTR MMT-7811NA GST3C LOCKOUT SENSOR, GLUCOSE, INVASIVE Back to Search Results
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.
 
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Brand NameXMTR MMT-7811NA GST3C LOCKOUT
Type of DeviceSENSOR, 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 Key7494652
MDR Text Key107607196
Report Number2032227-2018-02972
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-7811NA
Device Catalogue NumberMMT-7811NA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
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 Unkown

Patient Treatment Data
Date Received: 05/08/2018 Patient Sequence Number: 1
Treatment
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
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