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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 Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
Unit passed displacement test. Sleep current measurement and active current measurement within specifications. The power management tool indicated abnormal behavior of the lithium backup battery loaded voltage (loaded vlith) as shown on the power management graph and confirmed power error, low battery alarm due to connector resistance issue. After disconnecting and reconnecting the internal battery connector, the insulin pump was monitored and functioned properly. Unit received with cracked retainer, minor scratched display window, fading serial number label and scratched case.
 
Event Description
The customer reported via phone call that the insulin was squirting out during manual prime process. The customer's blood glucose was 145 mg/dl at the time of incident. The customer performed troubleshooting. The customer reported that the insulin did not continue to drip after letting go of the act button. There was no damage found on the insulin pump. The insulin pump was 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 Key7696812
MDR Text Key114480132
Report Number3004209178-2018-92927
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169656840
UDI-Public(01)00643169656840
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 05/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1G2FZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2016
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

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