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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 Device Displays Incorrect Message (2591)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Coma (2417)
Event Date 06/12/2018
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
Customer's spouse reported via phone call that customer received emergency medical assistance and got hospitalized due to low blood glucose on (b)(6) 2018 with blood glucose of 20 mg/dl at the time of the incident. The customer had high blood glucose and gave themselves a 6 unit bolus and a manual injection. The customer was at 316 mg/dl at the time of the call. The customer experienced symptoms such as a seizure and a coma. The customer was wearing the insulin pump during the incident. Troubleshooting was not completed as the caller declined. The customer got a motor error alarm while at the hospital. The customer recently lost their kidneys and was on dialysis. 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 Key7624141
MDR Text Key111830803
Report Number3004209178-2018-83740
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 consumer,other
Type of Report Initial
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
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 NumberA4751NASJ
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/04/2016
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: 06/21/2018 Patient Sequence Number: 1
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