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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAS
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 03/22/2017
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 that they were hospitalized due to high blood glucose. The customer was hospitalized either late (b)(6) 2017 or very early (b)(6)2017 with a blood glucose of 1300 mg/dl. She stated that she was moving and then started throwing up and her blood glucose was 500 mg/dl. The customer said she was going to take the pump off but could not wake up and cannot remember how long the pump was off of her. She stated that it wasn't the pump's fault. The ambulance came and took her to the hospital with a blood glucose of 1300 mg/dl. She believes that she had a stomach virus and was stressed from moving and work. The cause of the hospitalization was diabetic ketoacidosis. The customer said that she was in a coma for five days, was on life support and was released once her blood glucose was stable and she was out of the coma, which was on (b)(6) 2017. She said that she was not wearing the insulin pump at the time of the hospitalization and was without it for less than 48 hours. She declined troubleshooting. The insulin pump will not be returning for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751NAS
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 Key6718362
MDR Text Key80193990
Report Number2032227-2017-29027
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00643169503717
UDI-Public(01)00643169503717
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 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAS
Device Catalogue NumberMMT-751NAS
Device Lot NumberA4751NASJ
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 Received06/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/17/2017 Patient Sequence Number: 1
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