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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008A
Device Problems Loss of Power (1475); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
Patient Problem Hypoglycemia (1912)
Event Date 06/08/2017
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that he experienced a low blood glucose level in the 40's mg/dl. The customer stated that he was not sure of his blood glucose reading. Customer reported that he had issues with some of the sensors where the sensors do not work with the transmitter. The customer had issues with his blood glucose going low and the sensor would turn off. When the customer turned the sensor back on, he would see a message that said the sensor glucose value was not available. Customer would unhook the transmitter and try to reconnect but the green light would not come on. Customer would take it out and start over. Customer was advised to return the sensors. Customer declined troubleshooting and stated that all issues were user error. The customer just got his insulin pump today and has not had training. The sensors were returned for analysis. The insulin pump was not returned for analysis.
 
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Brand NameSENSOR ENLITE MMT-7008A
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
MDR Report Key7599206
MDR Text Key111008296
Report Number3004209178-2018-81005
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 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/27/2017
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Device Lot NumberHG1VBN3
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 Received07/26/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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