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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem Hyperglycemia (1905)
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
The customer's spouse reported via phone call the patient¿s the blood glucose was high and the sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s blood glucose was 150 mg/dl and the sensor glucose was 50 mg/dl at the time of the incident. The customer reported that the last 2 sensors were reading off. He drank orange juice and their blood glucose level ended up going up to 500 mg/dl as it was wrong. The customer treated it with manual injection and insulin pump. Now today he had the same issues. The insulin pump was shutting off his basal and can¿t get it on or shut the sensor off. Blood glucose was 129 mg/dl and sensor glucose was 83 mg/dl. Insulin pump was down in 50 mg/dl range. Previously blood glucose was 120 mg/dl, 152 mg/dl, 172 mg/dl, and 112 mg/dl. Previously blood glucose was 439 mg/dl. Insulin pump suspended on low. Sensor glucose and blood glucose difference was not within acceptable range. Previously blood glucose was 154 mg/dl and sensor glucose was 137 mg/dl. Insulin delivery was suspended due to sensor glucose values of 75 mg/dl. Suspend on low limit in sensor settings was 75 mg/dl. The sensor and insulin pump will not be returned for analysis.
 
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Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI  
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 Key7144567
MDR Text Key95719382
Report Number2032227-2017-76561
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
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG1LP3W
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 Received12/11/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/20/2017
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: 12/22/2017 Patient Sequence Number: 1
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