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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 Device Operates Differently Than Expected (2913)
Patient Problem Hypoglycemia (1912)
Event Date 08/14/2017
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 low blood glucose levels of 49 mg/dl. Customer has been having issues with battery failed alarm. Customer was assisted with troubleshooting. The customer's health care professional recommended that he make adjustments to his basal rates. Customer treated low blood glucose level by drinking apple juice and declined to troubleshoot for low blood glucose. The insulin pump will not be returned for analysis.

 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key7628547
MDR Text Key111980282
Report Number3004209178-2018-84261
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 06/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device LOT NumberHG1P2BL
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/23/2017
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: 06/22/2018 Patient Sequence Number: 1
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