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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-751LNAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751LNAB
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hyperglycemia (1905); Seizures (2063)
Event Date 12/08/2017
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
Customer reported via phone call that they had a grand mal seizure. Customer's blood glucose at the time of the incident was 345 mg/dl. She was taking a nap when it happened. Customer declined troubleshooting for high readings. The insulin pump will not be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751LNAB
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 Key7829107
MDR Text Key118641411
Report Number2032227-2018-20547
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 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751LNAB
Device Catalogue NumberMMT-751LNAB
Device Lot NumberA4751LNABJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2017
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: 08/29/2018 Patient Sequence Number: 1
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