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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-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAS
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Skin Irritation (2076)
Event Date 05/17/2017
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 via phone call that they were hospitalized due to low blood glucose and severe dehydration on (b)(6) 2018 with blood glucose of 34 mg/dl. The customer was treated with iv treatment in the hospital. The insulin pump had to shut off due to ambulance came. The customer reported other blood glucose values are 490 mg/dl, 94 mg/dl. The customer also reported that the insulin pump not using more than 48 hours when high blood glucose was reported. The customer was treated with manual injection for high blood glucose. The insulin pump will not be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751LNAS
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
8185464805
MDR Report Key8059278
MDR Text Key126906986
Report Number2032227-2018-59037
Device Sequence Number1
Product Code OZO
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
Type of Report Initial
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751LNAS
Device Catalogue NumberMMT-751LNAS
Device Lot NumberA5751LNASJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/28/2018
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: 11/12/2018 Patient Sequence Number: 1
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