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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 Problem Inaccurate Delivery (2339)
Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); Nausea (1970); Pain (1994)
Event Date 10/21/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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
The customer reported via phone call that the insulin pump was under delivering insulin and the blood glucose is high as 400 mg/dl at the time of the incident. The current blood glucose was 142 mg/dl. Customer had a lot of scar tissue, leukemia and stated that she always gets bruising and soreness on sites. Customer though this was normal since she has leukemia and several other health issues. Customer reported that, customer does not allege pump was under delivering. Customer reported the following symptoms related to their high blood glucose was nausea. Customer declined to continue pump troubleshooting for high blood glucose. Customer treated for high blood glucose with syringe. Assisted with performing the high pressure test and was passed. The insulin pump will not be returned for analysis.
 
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Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI  
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 Key6991889
MDR Text Key90737064
Report Number2032227-2017-63129
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
Type of Report Initial
Report Date 10/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG1XZZD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/31/2017 Patient Sequence Number: 1
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