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

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.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• Type of Device: ARTIFICIAL 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 Key: 7609708
• MDR Text Key: 111758108
• Report Number: 3004209178-2018-82650
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG19HSZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 175