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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-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-551NAS
Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591); Calibration Problem (2890)
Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)
Event Date 12/13/2017
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 the customer's had high blood glucose and low blood glucose and value 450 mg/dl and 39 mg/dl. The sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s current blood glucose was 101 mg/dl and the sensor glucose was 180 mg/dl. It also reported that insulin delivery was suspended due to sensor glucose values. The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. It also reported that the sensor glucose value that triggered the suspend event was 73 mg/dl and threshold suspend limit in sensor setting was 80 mg/dl. It was also reported that the customer blood glucose was over 200 mg/dl, 114 mg/dl and blood glucose value at reported event was 104 mg/dl and sensor glucose value at reported event was 125 mg/dl. The customer does not calibrate when her bg was 250 mg/dl or higher and does not calibrate when it's 60 mg/dl or below. The sensor and insulin pump will not be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-551NAS
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 Key7157149
MDR Text Key96147373
Report Number2032227-2018-00024
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 Patient
Type of Report Initial
Report Date 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-551NAS
Device Catalogue NumberMMT-551NAS
Device Lot NumberA6551NASJ
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 Received12/14/2017
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: 01/02/2018 Patient Sequence Number: 1
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