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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1714K
Device Problems Reservoir (934); Inaccurate Delivery (2339)
Patient Problem Hyperglycemia (1905)
Event Date 06/19/2018
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 reported via phone call high blood glucose levels and issues with the insulin pump. Customer¿s blood glucose level was 33 mmol/l. Customer treated their blood glucose levels via insulin pump. Customer advised they changed out their infusion set and reservoir. Customer believed the correction bolus they delivered was not accurate. However, customer advised the insulin pump passed the displacement test.

 
Manufacturer Narrative

Unit passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and the delivery accuracy test. Insulin flow blocked alarm functions properly during the basic occlusion test, occlusion test and force sensor test. No unexpected insulin flow blocked alarms noted during testing. No active insulin anomaly noted. Unit communicated properly with the test blood glucose meter. The meter sent the test value of 4. 8 mmol/l to the pump and was properly displayed on the pump screen. No pump/meter communication anomaly noted. The low reservoir alarm functions properly during testing. With 6 units remaining in the reservoir, programmed a 6. 0 unit bolus delivery. After the pump completed the 6. 0 unit bolus delivery, the pump triggered an alert, reservoir estimate at 0 unit. No low reservoir alarm anomaly or units left anomaly in the pump status screen noted.

 
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Brand NamePUMP MMT-1714K 630G BLACK MMOL CANADA
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 Key7648101
MDR Text Key112662423
Report Number3004209178-2018-86236
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1714K
Device Catalogue NumberMMT-1714K
Device LOT NumberHG2B4C4
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/04/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/08/2018
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: 06/28/2018 Patient Sequence Number: 1
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