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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-1715KR 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KR 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bronchitis (1752); Dyspnea (1816); Hyperglycemia (1905); Pneumonia (2011); Vomiting (2144); Diabetic Ketoacidosis (2364)
Event Date 12/23/2019
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 they were hospitalized on (b)(6) 2019 due to diabetic ketoacidosis with a high blood glucose level of 600 mg/dl.The customer reported that they were still in the hospital and mentioned that the blood glucose level was 480 mg/dl.The customer was using the insulin pump system within 48 hours of the reported high blood glucose event.The customer experienced shortness of breath and was also throwing up, pneumonia and bronchitis.The customer reported that they were treated with intravenous fluids and insulin and steroids.The insulin pump will not be returned for analysis.
 
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Brand Name
630G INSULIN PUMP MMT-1715KR 630G
Type of Device
ARTIFICIAL 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 Key9556681
MDR Text Key173885920
Report Number3004209178-2020-51906
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00763000173036
UDI-Public(01)00763000173036
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 Other
Type of Report Initial
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-1715KR
Device Catalogue NumberMMT-1715KR
Device Lot NumberHG32CE5
Was Device Available for Evaluation? No
Date Manufacturer Received01/02/2020
Date Device Manufactured12/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
FRN-UNK-RSVR, UNOMED INF SET
Patient Outcome(s) Hospitalization;
Patient Age61 YR
Patient Weight145
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