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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problems Break (1069); No Display/Image (1183); Display or Visual Feedback Problem (1184); Power Problem (3010)
Patient Problems Chest Pain (1776); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)
Event Date 05/02/2021
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 and high blood pressure on (b)(6) 2021, with blood glucose of 365 mg/dl. Customer was in emergency room as a result of high blood glucose level. The customer was treated with insulin pump. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer also stated that insulin pump had blank display. Customer stated that the display was not blank less than 30 seconds and did not return. Customer stated that the contacts on the battery cap were not missing or damaged. Customer did not allege that insulin pump was under delivering. The insulin pump will be returned for analysis.
 
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Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI  
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
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
7635140379
MDR Report Key11811520
MDR Text Key250180567
Report Number2032227-2021-144716
Device Sequence Number1
Product Code OZO
UDI-Device Identifier000000643169873834
UDI-Public(01)000000643169873834
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG2H8GM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-0955-2020

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
Treatment
FRN-UNK-RSVR, UNOMED INF SET
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