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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-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017); High Test Results (2457)
Patient Problem Hyperglycemia (1905)
Event Date 03/17/2018
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 the blood glucose was high. The customer reported that they were having high blood sugars. Customer stated she went to the hospital on (b)(6) 2018 for a back related issue. The hospital disconnected the infusion to do x-rays but they didn't perform them nor did they reconnect the set. The customer stated she didn't know she was disconnected and went to bed. Saturday night the blood sugars were 535mg/dl. Customer stated she was given a shot for pain and thought that was the reason for the high blood glucose until she realized the set was not connected. Customer treated the high blood glucose with boluses from the pump. Patient's current blood glucose was 203mg/dl. The customer treated high blood glucose by bolusing with the pump. Based on customer report customer does not allege pump was under delivering. No troubleshooting was done on the insulin pump. The insulin pump will not be returned for analysis.
 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key7409838
MDR Text Key104799839
Report Number3004209178-2018-63031
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 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1TKMN
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 Received03/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/30/2017
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: 04/09/2018 Patient Sequence Number: 1
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