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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Hyperglycemia (1905)
Event Date 06/30/2017
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
It was reported by the customer's parent that the customer received emergency medical assistance due to low blood glucose on (b)(6) 2017 with blood glucose of 38 mg/dl at the time of the incident. The customer was at 223 mg/dl 30 minutes before the call and 341 mg/dl at the time of the call. The caller states that the customer gave herself 20 units of insulin instead of the 10 they were supposed to give. The customer was given glucose, apple juice, and dessert to treat. The customer experienced symptoms such as being out of it. The customer was wearing the insulin pump during the incident. Troubleshooting was not completed as the caller declined. Caller states the customer had another low event 3 weeks prior and treated with orange juice, food, and glucose tablets. The customer also experienced a high after treating for the low, and used a manual injection of 5 units to treat. The insulin pump will 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 Key6723718
MDR Text Key80378833
Report Number2032227-2017-29550
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 other
Type of Report Initial
Report Date 07/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device Lot NumberHG1MYZZ
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/03/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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