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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 Improper or Incorrect Procedure or Method (2017); Moisture or Humidity Problem (2986)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2018
Event Type  malfunction  
Manufacturer Narrative
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
It was reported that the insulin pump had exposed to moisture. The customer¿s blood glucose level was 12. 9mmol/l the time of the incident. Customer stated insulin pump did not working at the time of call. Troubleshooting was performed. The insulin pump will be returned for analysis.
 
Manufacturer Narrative
Insulin pump received with blank display due to moisture damage on the electronic assembly. Unable to perform the self test, sleep current measurement, active current measurement, and displacement test due to blank display. Also, received with moisture damage on the motor and force sensor. No moisture damage was found on the keypad assembly.
 
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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
8185464805
MDR Report Key7693377
MDR Text Key114542801
Report Number3004209178-2018-92648
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 03/15/2019
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 Other
Device Model NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device Lot NumberHG2DMKN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2018
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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