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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 Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2017
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event. The device has been returned, but not yet evaluated. Further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
Customer reported via phone call that insulin pump hit the floor causing damage to the battery compartment and reservoir compartment. Customer reported that the reservoir fell out and was not able to lock in place. It was reported that the retainer ring was missing from the pump. Customer's blood glucose was 180 mg/dl at the time of incident. Troubleshooting was performed. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
The device had a missing retainer and missing reservoir tube o-ring. The reservoir did not lock in place due to missing retainer. Unable to perform the displacement test due to missing retainer.
 
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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
MDR Report Key7594787
MDR Text Key111059502
Report Number3004209178-2018-80315
Device Sequence Number1
Product Code OZO
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 Patient
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 05/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/12/2018
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 NumberHG1K9YK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2016
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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