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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 Failure To Adhere Or Bond (1031); Bent (1059); Component Missing (2306); High Readings (2459)
Patient Problem Hyperglycemia (1905)
Event Date 06/02/2017
Event Type  Injury  
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
 
Event Description
Customer reported via phone call that they were experiencing high blood glucose and issues with infusion set not adhering, bent cannula and one with missing cannula.Blood glucose was 383 at the time of the incident.The customer was assisted with troubleshooting for bent/missing cannula and high readings.The customer was advised of the proper preparation process and insertion techniques.The customer's blood glucose was ranging from 487 to 512 mg/dl and treated via bolus with the insulin pump.Customer was advised the infusion set will be replaced.The insulin pump will not be returned for analysis.
 
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Brand Name
PUMP MMT-1715KM 630G 3ML BLACK MEDI  
Type of Device
ARTIFICIAL 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 Key7662520
MDR Text Key113154633
Report Number3004209178-2018-87992
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169873834
UDI-Public(01)00643169873834
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 Other
Type of Report Initial
Report Date 07/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG1KX9Q
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/02/2017
Initial Date FDA Received07/04/2018
Date Device Manufactured01/05/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
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