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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 Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 04/14/2018
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
Customer reported via phone call for high blood glucose. Blood glucose was 586 mg/dl. Customer¿s blood glucose was 213 mg/dl. Customer reported that cgm said his blood glucose was 105 mg/dl or so, took a blood glucose was 98 mg/dl close and then went out had dinner with daughter came back and now took a look at insulin pump said that blood glucose was about 110 mg/dl got up this morning looked at the insulin pump again measured 110 mg/dl exactly the historical line was straight blood glucose was 586 mg/dl. Customer reported that after changing sensor, waited a few hours after blood glucose was got it down to 97 mg/dl or 96 mg/dl. Customer measure blood glucose after some times and the blood glucose value was 110 mg/dl and 240 mg/dl. Customer reported that last night blood glucose was up over 500 mg/dl and cgm was saying it was 100 mg/dl that¿s absurd. Customer reported that the sensor last night never recovered, blood glucose was up around 375 mg/dl when changed it out just giving himself insulin based on finger sticks didn¿t want to calibrate until decent blood glucose range, starts to calibrate when blood glucose is 220 mg/dl causes problems with sensor. Customer declined to troubleshoot for high blood glucose because ate too much and didn¿t count carbs before he ate. 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 Key7592323
MDR Text Key110783221
Report Number3004209178-2018-80107
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 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
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 NumberHG2614B
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 Received04/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/01/2017
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: 06/12/2018 Patient Sequence Number: 1
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