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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008A
Device Problems Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017); High Test Results (2457)
Patient Problem Hypoglycemia (1912)
Event Date 05/10/2018
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 received emergency medical assistance and got hospitalized due to low blood glucose on (b)(6) 2018 with blood glucose of 48 mg/dl at the time of the incident.The customer was driving and got involved in a car accident.The customer's sensor was reading at 85 to 100 mg/dl when the actual blood glucose was 48 mg/dl.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed.The customer had worn the sensor for 2 weeks and was aware that they should only wear it for 6 days.The insulin pump will not be returned for analysis.
 
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Brand Name
SENSOR ENLITE MMT-7008A
Type of Device
ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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 Key7613257
MDR Text Key111449060
Report Number2032227-2018-06471
Device Sequence Number1
Product Code OZO
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
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/13/2018
Initial Date FDA Received06/19/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age60 YR
Patient Weight203
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