• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 02/15/2018
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
The customer reported via phone call that he gave himself too much insulin and needed to turn off the insulin bolus. The customer reported that his sugar glucose was 9. 2 and he needed to suspend his insulin pump. The customer stated that he delivered his bolus about half hour and was trying to enter 30grams but accidentally entered 50 grams and now he had 20 units of insulin been delivered. The customer current blood glucose level was 17. 9 mmol/l. Troubleshooting was performed. The customer also stated that he had starchy dinner and caused his blood glucose levels to go high as 17. 9 mmol/l and then he went to treat for the high and entered the incorrect amount of carbs. The customer reported that he was experiencing low blood glucose levels about past half hour. The customer stated that his blood glucose level was 10 mmol/l. The patient treated the blood glucose with four sugar tablets and four tablespoons of sugar. During troubleshooting, the customer stated that they are unsure if the programming is accurate. The customer stated that the current blood glucose level was 7. 0 mmol/l. Troubleshooting was not completed at the time of call. The customer reported that the blood glucose level have been stable at 6. 6 mmol/l for the past 15 minutes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7310059
MDR Text Key101398185
Report Number3004209178-2018-54258
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 03/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
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 NumberHG1SFK8
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 Received02/15/2018
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: 03/02/2018 Patient Sequence Number: 1
-
-