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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 High Readings (2459)
Patient Problems Fatigue (1849); Hyperglycemia (1905)
Event Date 05/03/2017
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 experienced high blood glucose level of 580mg/dl.The customer was assisted with troubleshooting for the high readings.The customer had symptoms of tiredness.The customer treated with insulin pump bolus and syringe.Customer's blood glucose value was 256mg/dl at the time of the call.Customer reported that the high blood glucose levels began on (b)(6) 2017.The drive support cap appeared normal.There were no leaks or air bubbles.There were no site or insulin issues.The device settings were correct.The insulin pump passed the high pressure test.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's recommendation.The product 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 Key6609569
MDR Text Key76587892
Report Number3004209178-2017-51837
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169656840
UDI-Public(01)00643169656840
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 06/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1SK86
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2017
Date Device Manufactured04/12/2017
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 Age46 YR
Patient Weight192
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