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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)
Event Date 12/16/2019
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
The customer reported via phone call that they were hospitalized for diabetic ketoacidosis and high blood glucose on (b)(6) 2019. The customer was found in a seizure, but it was not insulin pump related. The customer was in intensive care unit and gave slow intravenous insulin and fluids to treat. The customer also experienced low blood glucose level and customer was on dialysis around the time of the incidents. The customer had been told not to use the insulin pump and was off insulin pump since (b)(6) 2019, but started using the insulin pump again when the high blood glucose event happened. The insulin pump will be returned for analysis.
 
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Brand Name630G INSULIN PUMP MMT-1715KL 630G
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
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
8185464805
MDR Report Key9826329
MDR Text Key188146763
Report Number3004209178-2020-84321
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
Type of Report Initial
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KL
Device Catalogue NumberMMT-1715KL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2019
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/12/2020 Patient Sequence Number: 1
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