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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1714K
Device Problems Fluid Leak (1250); Improper or Incorrect Procedure or Method (2017); Component Missing (2306); Device Operates Differently Than Expected (2913)
Patient Problem Hypoglycemia (1912)
Event Date 01/26/2018
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
It was reported via phone call that the insulin pump was not working well since it was dropped on the floor. It was mentioned they can smell insulin around the device. Blood glucose level was 8. 1mmol/l at the time of the incident. It was also reported that the customer had a low blood glucose event and discontinued the use of insulin pump. Customer was assisted performing the high pressure test. Self-test was performed and passed. However, there were missing segments identified on the display. The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan. The insulin pump was returned for analysis.
 
Manufacturer Narrative
Unit passed the sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test. No occlusion anomaly noted during testing. Unit was functioning properly.
 
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Brand NamePUMP MMT-1714K 630G BLACK MMOL CANADA
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 Key7601797
MDR Text Key111453645
Report Number3004209178-2018-81558
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device Lot NumberHG1WVMN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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