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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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hyperglycemia (1905)
Event Date 02/24/2018
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's mother reported via phone call that they were hospitalized due to diabetic ketoacidosis on (b)(6) 2018 at 6am with blood glucose value over 600 mg/dl. Customer¿s current blood glucose is 219 mg/dl. Customer stated he probably hadn't checked his glucose for a couple days until he started vomiting. Customer reports they have not contacted their healthcare professional regarding the high blood glucose. The customer was wearing the insulin pump during the hospitalization. Based on customer report customer does not allege pump was under delivering. Customer is not calling back to perform an high pressure test. The insulin pump will not be returned 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 Key7343382
MDR Text Key102570594
Report Number3004209178-2018-57160
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 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
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 NumberA2751NASJ
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2018
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: 03/15/2018 Patient Sequence Number: 1
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