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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1714K
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hyperglycemia (1905)
Event Date 02/14/2018
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
It was reported that the customer had high blood glucose levels of 24 mmol/l. The customer reported that his last blood glucose level was 20 mmol/l at 11 am which he bolused for. The customer reported that at 2 pm , his blood glucose level was 18. 3 mmol/l and the insulin pump did not ask him to bolus. The customer reported that he tested his blood glucose on the phone and his blood glucose was 24 mmol/l. The customer reported that he checked his bolus wizard and noticed it was turned off. The customer stated that he turned it back on and was able to bolus 10. 5 units. The customer stated that by accident he had turned off the insulin pump. Product is not expected to return.
 
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Brand NamePUMP MMT-1714K 630G BLACK MMOL CANADA
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 Key7305132
MDR Text Key101234142
Report Number3004209178-2018-53884
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device Lot NumberHG27404
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 Received02/14/2018
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: 02/28/2018 Patient Sequence Number: 1
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