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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 Problem Inaccurate Delivery (2339)
Patient Problem Hyperglycemia (1905)
Event Date 12/25/2017
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
The customer was reported via phone call that, the insulin pump under delivering the insulin with high blood glucose of 266 mg/dl.The current blood glucose was 126 mg/dl.Customer trouble with pump, gave self-insulin and still running high going on a while.Customer treated for high blood glucose with manual injections.Based on customer report proceeding in troubleshooting per customer alleging possible pump under delivery.Assisted with performing the high pressure test which was passed.Customer advised to change entire set, reservoir and insulin and treat per healthcare professional instructions.The insulin pump will not be returned for analysis.
 
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Brand Name
630G INSULIN PUMP MMT-1715K 630G BLACK MG
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
MDR Report Key7173678
MDR Text Key96696217
Report Number3004209178-2018-41623
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169656840
UDI-Public(01)00643169656840(017)20180611
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 01/08/2018
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 Expiration Date06/11/2018
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG26NNC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/26/2017
Initial Date FDA Received01/08/2018
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 Age56 YR
Patient Weight93
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