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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 Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Hyperglycemia (1905); Sepsis (2067)
Event Date 11/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 customer was in emergency room due to high blood glucose, urinary tract infection and diabetic ketoacidosis on (b)(6) 2019 with blood glucose level was above 526 mg/dl. The customer was assisted with troubleshooting declined for high blood glucose. The customer was treated with intravenous insulin and then subcutaneous insulin for high blood glucose. Customer was using insulin pump system within 48 hours of reported high blood glucose event. Customer reports they did not contact their health care professional regarding the high blood glucose. Customer stated that the caller primed the tubing halfway and wanted to know how completely fill it and saw a bubble in the reservoir. Customer stated that approximate size of air bubbles was bigger than a carbonation sized bubble. Customer stated location of air bubble was reservoir. The insulin pump as well as reservoir 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
8185464805
MDR Report Key9388474
MDR Text Key168447396
Report Number2032227-2019-124128
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 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1TC76
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/25/2017
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: 11/28/2019 Patient Sequence Number: 1
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