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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); Hyperglycemia (1905); Nausea (1970); Diabetic Ketoacidosis (2364); Abdominal Cramps (2543)
Event Date 09/21/2020
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
Customer reported via phone call that the customer was in emergency room where he was hospitalized for 3 days due to high blood glucose level and diabetic ketoacidosis on (b)(6).Customer¿s blood glucose level was 530 mg/dl at the time of hospitalization.Customer¿s current blood glucose level was 315 mg/dl and 285 mg/dl.Customer another blood glucose level was 350 mg/dl.On (b)(6) the cannula was bent in hospital.Customer was treated with manual injection and insulin pump.Customer was also treated with intravenous insulin drip.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer stated that the auto mode feature was not active at time of high blood glucose event.Customer reported that they had cramps, nausea and dehydrated symptoms.Customer was assisted with troubleshooting for high blood glucose level.The insulin pump will be returned for analysis.
 
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Brand Name
630G INSULIN PUMP MMT-1715K 630G BLACK MG
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
*  00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
*   00777-3869
Manufacturer Contact
gerwin de graaff
ceiba norte ind. park #50 road
juncos 00777--386
*   00777-3869
8185464805
MDR Report Key10790089
MDR Text Key214730526
Report Number2032227-2020-201510
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000316631
UDI-Public(01)000000763000316631
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 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG46L15
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/02/2020
Initial Date FDA Received11/05/2020
Date Device Manufactured03/17/2020
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-MMT-332A-RSVR, UNOMED SET
Patient Outcome(s) Hospitalization;
Patient Age61 YR
Patient Weight210
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