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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 Abdominal Pain (1685); Hyperglycemia (1905)
Event Date 11/26/2020
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call that they were hospitalized due to high blood glucose on unknown date, with unknown blood glucose level.Other values was 600 mg/dl.The customer was treated with intravenous drip.Customer had symptom like abdominal pain.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Customer was not using auto mode feature.The insulin pump will be returned for analysis.
 
Manufacturer Narrative
The additional information has been received which was not included in previous report.The information has been provided in this report.(b)(4).
 
Event Description
The customer reported via phone call that they were hospitalized on (b)(6) 2020 due to high blood glucose level of 600 mg/dl.The customer had fallen but it was unknown if it was due to diabetes related.
 
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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
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 Key11071200
MDR Text Key223582614
Report Number2032227-2020-220836
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000763000190439
UDI-Public(01)000000763000190439(17)220513
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,Followup
Report Date 01/20/2021
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 Expiration Date05/13/2022
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG3EEUN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/18/2020
Initial Date FDA Received12/24/2020
Supplement Dates Manufacturer Received01/15/2021
Supplement Dates FDA Received01/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/14/2019
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-332-RSVR, UNOMED INF SET
Patient Outcome(s) Hospitalization;
Patient Age69 YR
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