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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715K
Device Problem Inaccurate Delivery (2339)
Patient Problem Hypoglycemia (1912)
Event Date 06/08/2018
Event Type  Malfunction  
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.

 
Event Description

The customer called and reported that their insulin pump was delivering insulin after being suspended. The customer had disconnect the pump to stop from going lower. The customer¿s blood glucose level was 65 mg/dl at the time of the incident, and 79 mg/dl at the time of the call. The customer treated the low with food. Troubleshooting was completed but did not resolve the issue. The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan. The insulin pump will be returned for analysis.

 
Manufacturer Narrative

The pump passed the self test, sleep current measurement, active current measurement, rewind test, prime or seating, basic occlusion, occlusion, force sensor, displacement and the dat test at 0. 08730 inches. The pump was programmed with multiple boluses and monitored. All boluses delivered properly and were listed in the daily history screen. The pump then was programmed with multiple basal profiles and monitored. All basal profiles delivered their indicated amounts and were verified in the daily and summary history screens. The units left at the pump display matched properly the units left at test reservoir. No delivery anomaly, bolus anomaly or basal anomaly noted during testing. Installed a test reservoir and primed the pump. Pump basal rate was customer settings at time of return. Activated the suspend delivery feature and monitored the pump for three days. The pump remained on suspended delivery and did not resume any deliveries during monitoring period. No delivery or suspended delivery anomalies noted.

 
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Brand Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
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 Key7609708
MDR Text Key111758108
Report Number3004209178-2018-82650
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,Followup
Report Date 10/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-1715K
Device Catalogue NumberMMT-1715K
Device LOT NumberHG19HSZ
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/28/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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